The innovative drug Dupixent, developed by Sanofi and Regeneron Pharmaceuticals, has already made a significant impact in the treatment of various skin and lung disorders. Recently, it has received FDA approval for a new indication—chronic obstructive pulmonary disease (COPD), a lung condition generally associated with smoking but also found in non-smokers. This approval marks a notable expansion as Dupixent becomes the first biologic therapy authorized by the FDA for COPD. This disease causes lung damage leading to inflamed airways, difficulty breathing, coughing, and wheezing, traditionally managed using drugs that dilate airways and reduce inflammation.
Dupixent, an injectable biologic administered every other week, functions by targeting and inhibiting IL-13 and IL-4, two pathways known to propagate inflammatory responses. Specifically, in COPD patients, the drug focuses on type 2 inflammation which involves an excessive immune reaction characterized by an accumulation of eosinophils—an immune cell type—in tissues. The approval for this new application concerns its utilization as an add-on maintenance treatment for adults with COPD inadequately controlled by existing therapies.
The extension of Dupixent’s indications to include COPD stems from the results of two Phase 3 trials. These studies assessed the drug’s efficacy against a placebo in adults currently using inhaled standard care. Over a year, the trials recorded statistically noteworthy reductions in the annualized rate of moderate to severe COPD exacerbations among participants treated with Dupixent.
Dupixent’s successful trajectory began with its initial FDA approval in 2017 for the treatment of atopic dermatitis. It was further approved in 2018 for asthma, and now, it is indicated for a total of six different respiratory and dermatological conditions. According to Paul Rowe, Sanofi’s head of medical affairs specialty care in North America, this expansion into COPD treatment aligns with the positive outcomes observed in other disorders, providing a strong rationale for its use in treating COPD.
Financially, Dupixent has been a lucrative asset for Sanofi and Regeneron, achieving €10.7 billion (~$11.6 billion) in sales in 2023, marking nearly a 30% increase from the previous year. Under a collaborative agreement, Sanofi and Regeneron share the profits from the drug, with Sanofi recording all revenues from the antibodies generated by this partnership.
Dupixent’s entry into the COPD treatment arena could change the competitive landscape, marked by older, predominantly inhaled therapies. Innovation in this space is already observable with the recent FDA approval of Verona Pharma’s Ohtuvayre, another inhalable medication designed to manage inflammation and facilitate airway opening. Furthermore, the drug Nucala, developed by GSK, might emerge as a competitor. Having shown positive results in a recent Phase 3 COPD study, Nucala could represent a recovery from an initial FDA rejection for the same indication in 2018.
The approval process for Dupixent in COPD had faced a delay, originally anticipated in June, as the FDA required additional time to review more clinical data. However, following the final approval, regulatory bodies in China also approved the drug for COPD treatment, making it internationally recognized alongside its prior European approval.
This significant development not only broadens the therapeutic reach of Dupixent but also provides a vital additional treatment option for managing COPD, a disease that affects a considerable number of individuals worldwide, primarily those exposed to respiratory irritants like cigarette smoke.
#Sanofi #Regeneron #Biologic #Drug #Dupixent #Notches #FDA #Approval #COPD
