First Biologic Approval in COPD Achieved by Dupixent from Sanofi and Regeneron

First Biologic Approval in COPD Achieved by Dupixent from Sanofi and Regeneron

Sanofi and Regeneron are set to broaden the scope of their medication Dupixent. On Friday, Sanofi declared that the FDA has granted approval for this significant biologic as an adjunctive therapy for chronic obstructive pulmonary disease (COPD).

This marks Dupixent as the first biologic medicine in the U.S. authorized for COPD, according to the companies, which estimate it could assist around 300,000 adults dealing with poorly managed disease who also have elevated blood eosinophils, a type of inflammatory cell that contributes to airway blockage. COPD leads to a gradual decline in lung function and is recognized as the third leading cause of mortality globally.

In two Phase III clinical trials, Dupixent treatment demonstrated a 30% to 34% reduction in the annualized rate of moderate or severe exacerbations when compared to placebo. Additional improvements were noted in post-bronchodilator forced expiratory volume levels from baseline at week 12, marking the secondary endpoint.

The safety profile was consistent with those reported for Dupixent’s other approved uses, with the most frequently experienced adverse events indicated as viral infections, headache, and gastritis. The European Medicines Agency approved this biologic for use as an add-on maintenance treatment for uncontrolled COPD in July.

“Dupixent takes a pioneering step as the first and only approved add-on biologic therapy for inadequately controlled COPD, offering affected patients the potential for improved breathing and reduced exacerbations,” stated Sanofi CEO Paul Hudson.

The approval enriches the extensive list of FDA-approved indications for Dupixent, which also includes asthma and eczema.

In 2023, Dupixent generated .6 billion in revenue, with further estimates of an additional .5 billion expected from the COPD authorization, as noted by Fierce Pharma.

While Sanofi and Regeneron have achieved a milestone with this biologic for COPD, competitive developments are anticipated. Recently, GSK reported topline results from a Phase III study evaluating its injectable antibody Nucala for COPD. Although specific results have yet to be disclosed, the statement indicated that Nucala resulted in a “statistically significant and clinically meaningful reduction” in annual moderate or severe exacerbation rates compared to placebo. AstraZeneca and Amgen are also planning Phase III trials for Tezspire in the COPD indication.