What is the Lower Drug Costs Now Act of 2019?
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (cited as the Lower Drug Costs Now Act of 2019), is a bill before the House that is intended to make prescription drugs more affordable for those in the Medicare program. The bill also seeks to maintain Medicare’s future viability. H.R. 3 will accomplish this by making it legal and required for the Centers for Medicare and Medicaid Services to negotiate drug prices in the U.S. at levels comparable to those set by pharmaceutical companies for the same drugs sold in foreign industrialized markets.
More formally, H.R. 3 has been introduced “to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes.”
What does this bill have to do with the American pharmaceutical industry?
If H.R. 3 becomes law:
- It will become legal and required for the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for drugs meeting specific criteria and including insulin. The negotiated prices must be offered under Medicare and Medicare Advantage (MA). Private insurers may also be offered the negotiated price.
- The negotiated maximum price may not be higher than 120% of the average price in specific other industrialized companies. Drug companies failing to comply will face civil and tax penalties.
- The bill also includes rebates from drug manufacturers to CMS for covered drugs that have prices that rise more rapidly than the increase in inflation and reduces the annual out-of-pocket spending threshold.
Note: Changes to the original bill were made before approval by two Committees: Specifically, Energy and Commerceintroduced a price cap for new negotiated drugs until at least two or more generic competitors exist, as well as a phased-in increase in the minimum number of drugs Medicare must negotiate from 25 to 35. Education and Labor chiefly introduced clarification of the out-of-pocket cost limit and the requirement for GAO to conduct a study on the implementation of the Fair Price Negotiation Program, etc.
What’s happened in the House so far?
To date in 2019:
- Sep 19th – The bill was introduced in the House (116th Congress 2019-2020) by Democratic Messrs. Pallone of New Jersey for himself, Neal of Massachusetts, and Scott of Virginia. The bill was then referred to three committees: Energy and Commerce; Ways and Means; Education and Labor, “in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Sep 20th – The Committee on Energy and Commerce refer the bill to its Subcommittee on Health, with Hearings held on the 25th.
- Oct 17th – A Committee Consideration and Mark-up Session held, leading to a roll call vote that was carried by the ayes with a vote of 27-21.
- Oct 22nd – The bill, with changes noted above, reaches the Ways and Means Committee for a Consideration and Mark-up Session where it passes with a vote of 30-22.
What happens next?
H.R. 3 will go before the full House in mid-November. The bill, having passed in each committee, is expected to receive approval by the House. However, the process will not be without conflict between progressives and moderates in the Democratic party. Disagreement over the bill with Republicans is also anticipated, given that they have a measure of their own to propose in the Senate.
More Coverage to Come:
Positions Taken by Major Stakeholders
The Lead-Up to the House Vote
The Anticipated Benefits of the Act
Published on BioSpace
Foodborne illnesses are not only an unpleasant personal experience for millions of Americans each year, they’re a logistical concern for businesses, with the potential to drive and keep people (and their dollars) away for good. As our food supply becomes increasingly global, the ability to accurately and quickly identify the source of any pathogen causing a foodborne illness has become exponentially more difficult. To ensure the safety of what we eat, the Food and Drug Administration (FDA) plans to build upon its early success with digital technology and whole-genome sequencing for its New Era of Smarter Food Safety.
Whole-genome sequencing
At its simplest, a genome is the information a cell needs to create an organism. Since an organism’s genome is as unique as a fingerprint, sequencing that genome is the first step in being able to quickly identify just what is making a person sick. Scientists generate the sequence by gathering samples of a particular food in a sterile environment, mashing it up, and conducting the genome analysis. The result is the fingerprint for that specific entity.
The problem is, having this information on hand at the local level is useful only under very limited circumstances. For instance, it would be enough if a group of people became ill after eating a single meal with food sourced locally, in a single sitting at a single event. With a few calls, it might be possible to identify the food causing the illness and take steps to keep it from being shipped to new locations.
More common is the case in which a number of people with nothing in common at first become ill within days of one another. Making a match between the pathogen causing the illness and the pathogen in each food involved is still fairly straightforward – if everything is sourced locally. But what if some of the food comes from sources across the globe? How are the fingerprints for those foods going to be of use in stopping the spread of the illness to additional locations when there is no way to readily communicate with other localities?
GenomeTrakr
So, to bring whole-genome information into play on a global scale, the FDA created a United States-based open-source distributed network of labs in 2013. The result is GenomeTrakr – the stuff of foodie-sci-fi. It makes whole-genome sequences from foods around the world available globally. Any health agency, anywhere on the network, can upload data from a pathogen causing illness in their locality and receive information about entities that match or closely approximate that sequence. In effect, the power of the digital fingerprinting and related DNA sampling now in use in law enforcement can be put to work for foodborne illness outbreaks by either making a match or reporting that the match is likely to be found within a certain cluster of “related” genome sequences. This game-changing use of whole-genome sequencing has already helped to halt the spread of global foodborne pathogens several times.
A digital framework
But global genome sequencing is still not all that is needed to safeguard the food supply – and your health. Being able to readily access a whole-genome sequence can tell you which food is the culprit, but how do you know where the food originated, what path it took from field to plate, and where any additional product is currently located on its journey from field to plate?
The FDA’s remedy to this part of the challenge is to digitize the records kept at each step of a food’s journey through the global system. Rather than filling out a paper form that remains local or creating a paper-based dossier that travels with a food shipment, each step along the way will be documented in a globally accessible, digital format. The result will be a system that complements the GenomeTrakr by making it possible to trace the source of a foodborne pathogen to its point of origin in minutes rather than weeks or months.
Why does it matter? It matters because ready access to the genome, the origin, and the trail it traveled will make it possible to stop the flow of this food through the system: It will keep additional people from becoming ill.
A blueprint
As the first step in the FDA’s Strategic Blueprint for this New Era of Smarter Food Safety, agencies and companies from all parts of the food sector met in October to discuss the logistics of the new approach and offer input. Considerations ranging from ownership of the data to concerns about data transfer were among the many raised. These issues are not not only vital to the integrity of the data in the system, but will also result in a system we can count on when we sit down to eat.
Published on The Spoon
The October 31 deadline for a U.K. exit from the European Union (EU) is rapidly approaching without a deal in sight. The current political situation is unsettled; PM Johnson suspended Parliament – a move that resulted in a related ruling by the U. K. Supreme Court. Ongoing efforts to craft an acceptable alternative to a hard border in Ireland are so far unsuccessful. Most recently, French President Macron and others called for PM Johnson to revise his current Brexit plan by the end of the week.
A “No-Deal Brexit” will impact all aspects of life in the U.K. Of particular concerns are the nearly inevitable shortage and significant price increase for some foods, and the potential for a scarcity of drugs and medical devices. The U.K. government is working to ensure adequate quantities of medications and medical devices are on hand for the transition period that will follow any form of Brexit. As for the life sciences and biotech industries – it’s become increasingly clear they face acute disruption as a result of this period of uncertainty, whether or not a satisfactory deal is ultimately reached.
European Medicines Agency Move to Amsterdam
One Brexit-related change that has already occurred is the March 2019 European Medicines Agency (EMA) move from London to Amsterdam. The EMA, which regulates the quality and safety of medicine for the EU, moved its headquarters it must be located in an EU country. At the time of its closing in January 2019, The Guardian reported that “Simon Fraser, the vice chair of Chatham House and the former permanent secretary at the Foreign Office, wrote: “Losing the European Medicines Agency HQ is a significant loss for London and for the UK.” In that same report, The Guardian wrote that “In September it emerged that Britain’s leading role in evaluating new medicines for sale to patients across the EU had collapsed with no more work coming from Europe because of Brexit.”
Potential for Back-Ups at the Dover Crossing
One benefit of membership in the EU has been the lack of internal customs checks between the 28 member states. Unless a deal is reached that will continue this ease of travel, any freight coming in the U.K. at the Dover crossing will be subject to a customs check. This is extremely problematic since the Dover crossing was not designed to facilitate anything beyond the arrival of RORO (Roll On – Roll Off) freight onboard ferries. It is not possible to provide adequate space for customs checks of trucks traveling in and out of the port. Since Dover is the port of choice for more freight than the other crossing combined, a backup at this port will result in increased traffic at more distant points of entry. The combination of these factors will lengthen the time it takes to receive goods to and from the U.K. – especially problematic for firms using JIT (Just In Time Inventory) strategies in their manufacturing processes. For pharma and biotech companies, this includes the materials they require for their products
Potential Tariffs, Drug Permissions, etc.
Goods traveling within the EU are not subject to tariffs. Unless the U.K. reaches a satisfactory agreement before it leaves the EU, all manner of products – including drugs and medical devices – will be subject to possible tariffs resulting in higher prices for drugs and devices from the U.K. Also in question is the status of the regulations that make it possible for the U.K. to freely export its pharma products to members of the EU. Germany is of particular concern because its aging population has a need for these products and the money for their purchase. Barriers to trade with this market will have a significant effect on the U.K. pharma market. Patents, intellectual rights, and other aspects related to the production of drugs and medical devices also have the potential to become more complicated – and thereby more expensive.
Ability to Work and Information Sharing
Under the current EU agreements, researchers can easily work in the U.K. and vice versa. At the moment, there is great uncertainty about the future for these workers. If there is a no-deal Brexit, it is not at all clear what that will do to the status of researchers. The uncertainty is already causing difficulties as pharma companies are advised that they are not able to give firm commitments or certain answers to those concerned about the outcome of a no-deal Brexit. The impact on the ability to share patient data across borders is similarly a matter of concern since many clinical trials are in process within the EU. Once the U.K. is outside the EU, the sharing of patient data will become a critical concern. Especially in the area of rare disease research, where the number of patients involved in trials is definitionally small, the necessity of sharing any data leaves researchers concerned for their work.
Government and Industry Response to Uncertainty
The U.K. government has a site for Brexit Readiness that contains the best information available, as well as steps to take to prepare for Brexit. The U.K Bioindustry Association (BIA) for life sciences in the U.K. has a Brexit Portal, and is holding a series of webinars and talks (YouTube) leading up to October 31. BBC has an “Explainer” that addresses the components of Brexit.
Next Steps
In addition to the events taking place in the U.K. in the coming weeks, there will be a European Council Summer on October 17-18. The purpose of this summit is for the U.K. to secure a deal with EU leaders. Possible outcomes from this summit are a deal, a delay, or a no-deal exit. The U.K. pharma industry has a lot riding on the outcome.
Click here for the latest Brexit updates related to the industry.
Published on BioSpace
This article is brought to you by Cambridge Consultants, a global product development and technology consultancy firm that helps companies at every stage, from technology consulting and concept strategy to full product and service development. Cambridge Consultants was a Silver Sponsor of SynBioBeta 2019 this past October 1-3 in San Francisco, CA. They recently announced a new partnership with Hitachi Central Research Laboratory in Japan to address the global challenge of plastic waste.
Chances are, you’ve personally used or benefitted from bioproducts – products made from renewable biologic materials. Alternative protein sources such as the Impossible Burger and Pivot Bio’s nitrogen-fixing PROVEN™ fertilizer are just two of many successful bioproducts. In December, North Face Japan will offer the Moon Parka – a high-performance ski parka manufactured with Spiber, Inc.’s bioengineered spider silk. Geltor’s HumaColl21TM , a biocompatible collagen for human skin cells, is a key component of Kolam Korea’s anti-aging face cream. Once bioproducts like these reach the market, it’s easy to overlook the fact that the work needed to adapt a biological process for use in the manufacture of a marketable product is just one step in a complex series of steps necessary for success.
The process of bringing a bioproduct to market is a challenge for a number of reasons. At the start of the process, it’s often the case that entrepreneurs with a technological capability struggle to find a real-world use for that technology. Once a use is identified, there must be an associated product, process, or service that compels consumers to become customers. As with any product, positioning in the marketplace with an eye toward positive consumer reaction is essential. When each of these stages has been accomplished, bioproducts generally face an additional hitch in the fact that, despite their environmental friendliness and sustainability, the public and regulatory agencies tend to be wary at best.
Advice on how to navigate such challenges is essential for many young startups in the biotech and synthetic biology space. Cambridge Consultants, a UK-based firm, assists synthetic biology companies around the world at all stages of the product life cycle. Over the years, James Hallinan, Business Development Manager of Synthetic Biology at Cambridge Consultants, has studied the success of a wide range of companies.
“It’s not just about having a great idea,” he says. “It’s about having a great idea that is executed well.” He identifies three traits that are especially important in a successful company: perseverance, flexibility, and execution. Here are three companies that exemplify how each of these challenges can be successfully met.
Perseverance – AquaBounty Technologies
“The first lesson,” says Hallinan, “is about perseverance as a really critical component.” AquaBounty is a prime example. In 1989, Garth Fletcher – co-inventor of GM salmon – and his team found they could use advanced molecular genetics to increase the growth rate of Atlantic salmon. The increase in growth rate was enough to shorten the time required to bring salmon to marketable size. With a shorter growing time, less food for the fish was required. It was also possible to grow the fish inland, rather than in fish farms in the ocean. These factors led to lower costs and a reduced environmental impact.
With all of the benefits, it would seem that AquaBounty’s AquaAdvantage Atlantic salmon would be a sure hit. But consumers and the FDA were not ready for GM salmon in 1995 when the first application was submitted. For that matter, they were not ready in the early 2000s. One of the concerns was that the genetic modification would reach the native salmon population despite the fact that the fish grown from AquaBounty eggs are sterile females. It was not until nineteen years later that the salmon received approval for consumption in the U.S. AquaAdvantage Atlantic Salmon is expected to hit grocers’ shelves in 2020.
“What I really admire about [AquaBounty],” says Hallinan, “is that they had the persistence to just keep going” even when the public wasn’t ready for their product and they had to continue on despite that. “I think that on a larger scale, aquaculture is going to become increasingly important as we start to reduce the use of protein sources with significant greenhouse gas impacts like beef and pork.”
Flexibility – Oxford Biomedica
It’s entirely possible to have a great idea and set out to pursue it to what seems to you to be the logical conclusion. Frequently, this does not lead to success because the position you envision for your company is not the position the market will support. In the case of Oxford Biomedica, the original plan was to produce treatments for neurodegenerative disease and spinal cord repair,” says Hallinan.
“They were a classic biotech developing biological drugs. But the challenge to entering the market was that it’s a high-risk endeavor.” Testing the product and coming up with a viable product requires a lot of time and capital.
Lack of initial success left Oxford Biomedica to rethink their goal. They decided to pivot from being a company where the therapy was the aim to one where a product to help others to create therapies was the aim. Their LentiVector® delivery platform is the basis of their partnerships with companies like Novartis. The partnerships bring income to Oxford Biomedica while making it possible for Novartis and others to have a reliable, stable source of material.
“Oxford Biomedica is now the world’s largest provider of viruses for selling gene therapy,” says Hallinan. They are so successful, he says, “because even when you get your product and you’re starting to target the market you may find that you need to pivot, and you need to pivot effectively. Oxford Biomedica was not a tiny startup when they pivoted. They were an established company with a couple of hundred people. It was a big thing for them to change direction, but they’ve done that, and they’ve done that successfully. Now they’re in a position where they’re selling their product at significant scale.”
Execution – Berkeley Lights
“You sometimes need to do something really different in order to make an impact,” says Hallinan. Using the example of taking a collection of cells and isolating some population from that group of cells, Hallinan emphasized that people have been using technology that “hasn’t really advanced significantly for the best part of three decades.”
Until now, that is. A company called Berkeley Lights, in recognizing the bottleneck created by the massive amount of data created during antibody discovery, has successfully made an impact by doing things “really differently.” As Hallinan puts it, “Berkeley lights set out to create an entirely new architecture.”
Their desired architecture optimized throughput and permitted greater precision and control — down to the individual cell level. The company developed an optofluidic-based technology to achieve this goal, and their platform now enables real-time, non-destructive, and manufacturing-relevant analysis with optimized multiple serial assays across thousands of clonal populations in a single experiment. Berkeley Lights’ ability to deliver — in a big way — disrupted an entire industry.
AquaBounty, Oxford Biomedica, and Berkeley Lights are just three examples of how companies in this space can successfully address and overcome the challenges unique to bringing a bioproduct to market. With more companies following their lead, it’s only a matter of time until the power of synthetic biology changes our world forever.
Published on SynbioBeta
Opioid abuse and addiction continue to ravage communities across the United States. Nora Freeman Engstrom of Stanford Law School reported in Suing the Opioid Companies, on August 30, 2018, that 2.4 million Americans had an opioid-use disorder with 300,000 lives lost, including 42,000 in 2016 alone. The financial burden on state governments in the form of increases in the cost for public health services, law enforcement, medical treatment, rehabilitation programs, housing, and related services has left state governments seeking the funds required to adequately deal with this crisis. Oklahoma was the first state to file suit against opioid manufacturers. The success of their legal strategy will have a significant impact on the opioid–and pharmaceutical–industry going forward.
What Oklahoma claimed
In the Judgement After Non-Jury Trial for the State of Oklahoma vs. Multiple Pharmaceutical Defendants in the District Court of Cleveland County during the spring/summer of 2019, the document shows that the state of Oklahoma claimed the defendants caused a public nuisance, for which the state was seeking relief in the form of “abatement of the nuisance.” None of the parties disputed the fact that Oklahoma was suffering a crisis related to the use of opioid drugs. They also agreed on several other indicators of the extent of this crisis, including the fact that in 2015, enough opioid pills were dispensed in Oklahoma “for every adult to have 110 pills.”
In his ruling, Judge Thad Balkman wrote that the challenged conduct was the “Defendants’ “misleading marketing and promotion of opioids. … Defendants engaged in a false, misleading, and deceptive marketing campaign designed to convince Oklahoma doctors, patients, and the public at large that opioids were safe and effective for the long-term treatment of chronic, non-malignant pain. The greater weight of the evidence shows that Defendants did, in fact, engage in such false and misleading marketing and the law is clear that such conduct qualifies as the kind of act or omission capable of sustaining liability under Oklahoma’s nuisance law.”
The action by the state of Oklahoma was successful where the suits of individuals and class action had not been because the individual and class action suits dealt with the specifics of an individual or group. Since the medications in question were FDA-approved and the individuals had chosen to take the medication, it was difficult to prevail. With class action suits, it was extremely difficult to assemble a group that had enough of the essential traits in common for the suit to succeed. By using the fact that the opioid addiction situation in Oklahoma was a crisis that had created a public nuisance, delving into the private lives of specific individuals was not required.
Ultimately, the court agreed that the defendants had caused a nuisance as defined to consist “in unlawfully doing an act, omitting to perform a duty, which act or omission annoys, injures or endangers the comfort, repose, health or safety of others; or, in any way renders other persons insecure in life, or in the use of property…” Judge Balkman ordered Johnson & Johnson to pay $572 million – an amount significantly less than sought, but one The New York Times reported would pay for a year’s worth of the services needed to combat the epidemic in Oklahoma. Purdue Pharma settled for $270 million in this same suit, one of the many in which it was named as a defendant.
Purdue Pharma, together with members of the Sackler family that own the company, is the name in a large opioid settlement relating to a lawsuit. Filed in December 2018 by Connecticut and a number of other states, it alleges that the company continued to push patients toward OxyContin® even after the addiction rate became evident. Connecticut Attorney General William Tong told ABC News in April 2019, “Our investigation left no room for doubt—Purdue and the Sacklers ignored all human cost while pushing deadly opioids in blind pursuit of profit.”
In a September 9th interview on NPR with North Carolina Attorney General Josh Stein, host Brian Mann – who covers opioid litigation for NPR – explained that “there’s a legal argument being made by some of these states [still seeking abatement] that the Sacklers effectively stripped billions of dollars out of Purdue Pharma over the years. In part, it’s alleged, because the family suspected their company would eventually face lawsuits like this. So, 17 states are already suing the Sacklers Directly to try to claw back some of these profits.” Stein agreed, stating “many states, like mine, will be filing lawsuits against the Sacklers in their individual capacity in creating this epidemic. I think almost more than any other family and company, they have to wear that burden.” On September 15, Purdue Pharma filed for bankruptcy in Chapter 11 as part of their $3 billion settlement of the 2018 suit. Whether or not future litigation directly against family members will succeed remains to be seen.
What it Means for Pharma
In the opinion of Stanford legal experts Michelle Mello and Nora Freeman Engstrom in an August paper, the outcome of the case was not a foregone conclusion. Nuisance claims are very hard to prove and by the time the suit went to court, “Oklahoma’s various causes of action got winnowed down to the singular claim that J&H had created a public nuisance by aggressively and deceptively marketing opioid products to Oklahoma’s doctors and patients.” As the first case of its kind, the Oklahoma case is a bellwether case – it leads the way to future litigation.
“The verdict,” say the authors, “suggests that this litigation has legs, and that judges and juries may be willing to pin blame not just on Purdue, the maker of OxyContin®, but on others who played an arguably less central role in fueling this public health crisis.” This has to be a concern to pharma companies and others in the industry alike. The fact that FDA-approved opioid drugs, marketed and sold through widely accepted means, have been the target of successful litigation as a public nuisance is certainly a game changer. The potential culpability of companies in the pharma space has undergone a paradigm shift.
Mello and Engstrom summed it up well. “What is striking is how damming Judge Balkman’s factual conclusions about J&J’s conduct are, and how similar they are to the allegations made against other opioid manufacturers in other cases. All the things he objected to regarding J&J’s marketing practices are things that others, too, allegedly have done. Some of them are things that multiple companies banded together to do. Plaintiff’s attorneys should be feeling pretty confident about their chances of persuading other courts that those practices are problematic.”
Published on BioSpace
Although asthma is a common chronic disease, there is currently no cure for it. Currently, physicians use a variety of means to reduce inflammation and keep it at bay. The extent of their success depends upon environmental factors, patient compliance and the “fit” of the treatment.
For those with chronic, moderate-to-severe asthma, corticosteroids are used to reduce inflammation. These conventional drugs are anti-inflammatory medications that may be used in inhalers on a daily basis or taken orally on a tapering dose when an exacerbation occurs. One of the drawbacks of corticosteroids is side effects that can come along with them, including a cough, minor nosebleeds, oral thrush and difficulty speaking.
The side effects from long-term or high-dose oral steroid are a cause for concern as well. Some of those side effects include osteoporosis, glaucoma, diabetes, high blood pressure, heart disease, Cushing Syndrome and many others. A therapy that leads to fewer asthma attacks while reducing the need for corticosteroids is ideal, especially for those who continue to have severe symptoms while using traditional therapies. That’s where biologics come in.
Biologics for Asthma
Biologics are drugs made from biological sources. To manufacture these drugs, a piece of DNA is inserted into a living cell. The cell follows the instructions in the DNA to produce a large amount of a protein molecule. The protein molecule is separated from the rest of the material and becomes the active ingredient in the biologic drug. Systemic reactions are possible with biologics because the proteins are large and can trigger an immune response in the patient. Also, since the chemical bonds holding the molecules together are weak, sudden changes of temperature can damage or degrade the molecules. Because of this, it is imperative that the entire manufacturing process of a biologic drug occur under precise, optimal, monitored conditions.
The exact mechanism for a biologic is unknown: The manufacturers of these drugs cannot tell you precisely how or why they work. However, they can provide you with the theory and rationale for the combination of DNA and cells they used. Clinical trials are then done to ensure that the finished biologic produces the anticipated results. Once this has been demonstrated, FDA approval is sought. FDA approval has been received for several injectable asthma medications.
Which Biologic
There are currently two identified mechanisms that cause the inflammation in asthma and are targets for treatment. One has to do with the IgE levels in a patient’s blood. The other has to do with the number of eosinophils. Eosinophils are present in everybody’s blood. It is when they exist in numbers that contribute to inflammation in the airways that they become a treatment target.
Because there is not one perfect biologic treatment for every patient with asthma, it isn’t unusual for one allergist’s practice to use several different biologics for their patients. Dr. Rachel Schreiber has been using biologics for more than 15 years.
“We use Omalizumab (Xolair), Mepolizumab (Nucala), Benralizumab (Fasenra), and Dupilumab (Dupixent). Each is indicated for moderate to severe persistent asthma. Xolair is also approved for use in chronic urticaria, Schreiber said. “Dupilumab is also approved for atopic dermatitis and nasal polyposis.”
Xolair® (omalizumab) is used in combination with other treatments to treat allergic (IgE) asthma and chronic urticaria (hives). Developed by Genentech and licensed by Novartis, Xolair received FDA approval in 2003. By targeting the IgEs in a reaction, Xolair reduces or prevents inflammation in patients with asthma that is not controlled by inhaled corticosteroids.
Essentially, Xolair does its work once an allergen is inhaled. Researchers know that the body creates IgE (immunoglobulin E) to attach to the allergen and the cell when the allergen is introduced. This causes inflammation of the airway, which can lead to an asthma attack. Researchers speculate that Xolair may work by binding to the IgE and preventing it from binding to the inflammatory cell.
Nucala® (mepolizumab) is used in combination with other treatments to treat severe eosinophilic asthma. Produced by GSK, it was approved in 2015 for the treatment of severe asthma. The type of asthma Nucala targets is caused by eosinophils that cause inflammation in the lungs. By reducing the number of eosinophilic cells, Nucala reduces the inflammation in the lungs.
Fasenra® (benralizumab) was approved to treat severe eosinophilic asthma in 2017. This biologic is manufactured by AstraZeneca. It is an add-on treatment that also reduces the number of eosinophils in the patient’s blood.
Dupixent® (dupilumab) is also used as an add-on maintenance treatment for eosinophilic asthma. Approved by the FDA in 2018 for the treatment of moderate-to-severe asthma. A product of Sanofi and Regeneron, Dupixent works by blocking two key sources of inflammation – IgE and eosinophils. It also blocks FeNo, which is linked to inflammation in asthmatic patients.
Selecting the appropriate treatment depends on a variety of factors. Schreiber says, “There are risks and benefits to each [treatment] and given the patient’s overall profile we make decisions about what we think may be most effective for the individual patient.”
Why Use a Biologic
Even with the oversight of a physician trained in the intricacies of asthma management, it might seem that the use of a large-protein therapy that can induce a reaction in the patient receiving an injection for the treatment of asthma is not worth the risk. It might also seem that a judicious use of both inhaled and oral corticosteroids could be used to adequately control inflammation in the lungs. Unfortunately for patients with severe asthma, the use of the latter has not been the case, while the risks of the former must be weighed against the effects of severe asthma and the traditional medications used for its control.
Because there is no on/off switch for the immune system response that triggers the inflammation in severe asthma, there are new biologics in the pipeline that are designed to better meet existing patients or the needs of entirely new populations of patient.
“These drugs help us decrease inhaled and oral corticosteroid use, asthma exacerbation rates, and hospitalizations and ER visits due to asthma,” Schreiber said. ’They make our patients feel better and have fewer symptomatic days. Biologic medications are state of the art and I believe they are the future as well.”
Published on BioSpace