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The blockbuster Sanofi and Regeneron Pharmaceuticals drug Dupixent, already commercialized in several skin and lung disorders, has expanded its FDA-approval to chronic obstructive pulmonary disease (COPD), a progressive lung condition prevalent in smokers. The regulatory decision announced Friday permits Dupixent’s use as an add-on maintenance treatment of adults whose COPD is inadequately controlled by available therapies. The every-other-week injectable drug is now the first biologic therapy approved by the FDA for treating COPD. In COPD, damage to the lungs leads to inflamed airways that cause breathing difficulty, coughing, and wheezing. The disease can be caused by long-term exposure to inhaled irritants, which is why it’s prevalent in smokers. But non-smokers can also develop COPD. Standard treatment includes drugs and drug combinations that widen airways and reduce inflammation. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum Dupixent is an antibody designed to block IL-13 and IL-4, two signaling pathways that drive inflammation. In COPD, the drug is intended to specifically address type 2 inflammation, an excessive immune response characterized by accumulation of certain immune cells in tissue. Dupixent’s FDA approval in COPD covers the drug’s use to treat patients whose disease is driven by immune cells called eosinophils. The FDA approval in COPD is based on results from two Phase 3 tests that compared the drug to a placebo in adults who were currently receiving standard-of-care inhaled therapy. Results for both studies showed statistically significant reductions in the annualized rate of moderate or severe COPD exacerbations measured over one year. Dupixent has been developed under a partnership between Sanofi and Regeneron, who share in profits from the drug. Sanofi recognizes all revenue from antibodies in the partnership. The drug accounted for €10.7 billion (about $11.6 billion) in sales in 2023, up nearly 30% from the prior year, according to the pharma giant’s annual report. Dupixent gives Sanofi a pipeline in a product opportunity, Paul Rowe, Sanofi’s head of medical affairs specialty care North America, said in an interview ahead of the FDA decision. The drug was first approved in 2017 for treating for atopic dermatitis followed by asthma in 2018. With the latest FDA nod, the drug can now treat six respiratory and dermatological conditions. “Given success we’ve had in these other disorders, we think there’s a strong rationale for COPD as well,” Rowe said. Sponsored Post Get Ready for HLTH 2024: A Preview Guide HLTH 2024, scheduled for October 20-23 at the Venetian Expo Center in Las Vegas, will highlight new programming, a physicians roundtable, generative AI, the shifting landscapes of telemedicine, retail health, women's health, and lots more. By Stephanie Baum COPD treatment has mainly consisted of older drugs, mostly inhaled therapies, but that’s changing. In June, the FDA approved Verona Pharma’s Ohtuvayre, an inhalable drug that hits two targets, one to counteract inflammation and the other to open up airways. Dupixent could also face new biologic competition. Nucala, a GSK antibody that blocks the IL-5 pathway, recently posted positive Phase 3 data in a COPD study. The results could represent a comeback for Nucala, which the FDA rejected for COPD in 2018. The injectable GSK drug is currently approved for treating asthma. An FDA decision for Dupixent in COPD was initially expected in June. But in May, the agency notified the company it needed more time to review additional clinical data it had requested. In a separate Friday decision, regulators in China approved Dupixent for COPD, Sanofi and Regeneron said. Dupixent’s first approval in COPD was in Europe, a regulatory decision handed out in July.

After more than a decade with no new treatments for chronic obstructive pulmonary disorder, the FDA has approved two new therapies for the disease in the last three months. The latest nod comes for Regeneron and Sanofi's Dupixent. After more than a decade without any therapeutic advancements in chronic obstructive pulmonary disorder (COPD), people with the progressive disease suddenly have two new options, with more likely on the way.Regeneron and Sanofi have announced that the FDA has expanded the label of megablockbuster Dupixent to treat COPD. The approval brings the versatile drug’s count of U.S. indications up to six, with its first coming seven years ago for atopic dermatitis.With the label expansion, Dupixent becomes the first biologic treatment for COPD patients in the U.S. The IL-4 and IL-13 inhibitor is approved to be used as an add-on maintenance treatment by adults with inadequately controlled COPD who have a raised blood eosinophil count (BEC).Two months ago, the European Medicines Agency approved Dupixent in the indication. Authorities in China did the same on Friday. In the U.S., there are approximately 2 million people with COPD, including 300,000 whose disease is classified as inadequately controlled. COPD is an inflammatory respiratory condition that restricts airflow from the lungs and leaves patients struggling to breathe. It causes progressive lung function decline and is the fourth leading cause of death worldwide.“People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalization,” COPD Foundation CEO Jean Wright, M.D., said in a release. “These patients often struggle with everyday activities many people take for granted such as taking a walk or running errands outside the home. We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease.”The nod comes after U.S. regulators delayed their decision date by three months, requesting additional results from two trials that had set Dupixent up for approval. Weeks before the FDA's decision, Regeneron CEO Len Schleifer, M.D., Ph.D., had indicated that the agency wanted to see sub-population breakdowns from the studies to make sure a specific group wasn’t “driving the data.”Dupixent is one of several new medicines coming to the fore in COPD. Three months ago, the U.S. regulator endorsed Verona Pharma’s Ohtuvayre, a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, which has the unique ability to both open the airways of patients and reduce their inflammation. It has been blessed as a monotherapy and as an add-on to current treatments.Other companies are rushing to the space with prospective COPD medicines. Two weeks ago, GSK reported that its respiratory blockbuster Nucala plus inhaled maintenance therapy lowered the rate of moderate or severe exacerbations among COPD patients for up to two years.Amgen and AstraZeneca have hopes for their asthma drug Tezspire as a potential treatment for COPD, as it has shown effectiveness in treating patients with a high BEC. Additionally, Regeneron and Sanofi have a second COPD candidate in IL-33 inhibitor itepekimab, which is being tested in two phase 3 trials.Over the last decade, as other companies—such as AstraZeneca with IL-5 inhibitor Fasenra—struggled to advance candidates for COPD, Regeneron and Sanofi took a more “phenotype-driven approach,” to show the value of their candidates in patient subsets, Sanofi’s immunology franchise chief, Manuela Buxo, said in an interview with Fierce Pharma in April.“It’s a very heterogeneous disease, so studying a broad patient population is probably not the right approach,” Buxo said. “With Dupixent we really focus on type 2 inflammation within the COPD patient population. And then with itepekimab we focus on former smokers. That approach seems to be working better than taking a broad-stroke approach. The reality is that we’re still learning about COPD patients.” The companies began testing Dupixent in COPD in 2018, taking a risk by going straight to phase 3. When interim results for the BOREAS trial were positive, Sanofi kicked off a second phase 3 trial, NOTUS.The trials—with a combined 1,874 patients on maximal standard of care inhaled therapy and most on triple therapy—showed that Dupixent reduced moderate or severe exacerbations by 30% and 34% respectively when compared to placebo. It also produced superior lung function within 12 weeks which, sustained through 52 weeks.The companies believe that Dupixent—given its track record—will be well received upon its launch.“There’s an urgency to treat. Those people can’t wait. Every exacerbation gets them closer to death, unfortunately,” Buxo said. “We already have established relationships with a large proportion of pulmonologists because they’ve been treating asthma patients.” Buxo said that the company will work with doctors to get them familiar with type 2 inflammation and BEC measurements. Patient awareness also is a factor as Dupixent brightens the prospects of those who may feel “resigned to their fate,” Buxo said, because of the previous lack of treatment options.Therapies commonly used to control COPD are inhaled corticosteroids, which reduce inflammation, and bronchodilators, which relax muscles in the lungs and widen the airways. Bronchodilators include long-acting beta agonists (LABAs) and long-acting muscarinic agonists (LAMAs). Some COPD patients are on a regimen with all three treatments. Others, who can’t take corticosteroids, use a LAMA and LABA mix.The COPD nod will give an added boost to the already-booming sales of Dupixent, which generated $11.6 billion last year, a 33% increase from 2022.Analysts at Evercore ISI have projected that a label expansion for COPD would add $3.5 billion in peak sales for Dupixent worldwide. They based their figure on 30% uptake of the treatment for those who are eligible. The addition would put Dupixent’s sales potential at $20 billion by the end of this decade, making it one of the highest-selling drugs of all time.  

The biggest drug driving Sanofi’s and Regeneron’s businesses is about to get a bit bigger. On Friday, the FDA approved Dupixent as an add-on to typical inhaled medicines for patients with inadequately controlled COPD, or chronic obstructive pulmonary disease, and high levels of a type of white blood cell called eosinophils. China regulators also granted a similar approval in COPD on Friday . The drugmakers estimate 300,000 people in the US fall under that description, representing a lucrative new market for the megablockbuster as well as a new treatment option for the hard-to-treat lung condition. “The latest approval in COPD represents an incredible next chapter for Dupixent, giving those with COPD a novel option that has demonstrated the unprecedented ability to help patients experience fewer attacks, while also helping them breathe better and improve quality of life in Phase 3 trials,” George Yancopoulos, Regeneron’s chief scientific officer, said in a statement. Since it was first approved in 2017, Dupixent has exploded into a business-defining drug for Regeneron and Sanofi, which co-developed the antibody that blocks IL-4 and IL-13. The drug has won approvals for a range of diseases driven by allergy or inflammation, such as eczema and asthma. Dupixent brought in about $6.6 billion in sales for the first half of 2024. In a research note to investors in August, Evercore ISI analyst Cory Kasimov forecast that Dupixent will generate $14.5 billion in sales for the year. The COPD market is key in continuing Dupixent’s relentless growth. In a note earlier this month, Jefferies analyst Akash Tewari said he expects $3.8 billion in peak sales of Dupixent in COPD, above a Wall Street consensus of $3.3 billion. In a pair of Phase 3 studies, COPD patients treated with Dupixent experienced roughly one-third fewer COPD attacks than a placebo group over the course of a year. The studies only enrolled patients with blood eosinophil levels of at least 300 cells per microliter. Dupixent is now the first biologic approved to treat COPD, but rival drugs may not be far behind. Earlier this month, GSK said its IL-5-targeting antibody Nucala succeeded in a Phase 3 COPD study . AstraZeneca and Amgen are planning a Phase 3 program for Tezspire in COPD after proof-of-concept results in a Phase 2a study were presented this May . Roche expects Phase 3 results next year for an antibody called astegolimab. Sanofi and Regeneron are also testing a combination of Dupixent and an IL-33 antibody called itepekimab to treat a broader swath of COPD patients. They expect Phase 3 results in the second half of 2025.