After a decade without significant therapeutic advancements for chronic obstructive pulmonary disorder (COPD), Regeneron and Sanofi have announced that the FDA has approved Dupixent as the first biologic treatment for adults with inadequately controlled COPD. This expanded approval marks a significant milestone for the drug, which now has six indications, and follows recent successes in trials that demonstrated a 30-34% reduction in moderate or severe exacerbations and improved lung function within 12 weeks.

The approval of Dupixent is especially critical for the approximately 300,000 U.S. patients classified as inadequately controlled, as they often struggle with debilitating symptoms like breathlessness and chronic coughing. Jean Wright, CEO of the COPD Foundation, emphasized the long-awaited need for effective treatments to help manage these patients' daily suffering. The positive interim results from the BOREAS trial led to the launch of the NOTUS trial, further reinforcing Dupixent’s potential to significantly improve patient outcomes.

As interest in COPD therapies grows, other companies are also advancing their candidates in this space. Verona Pharma’s Ohtuvayre recently received FDA endorsement, while GSK and AstraZeneca are exploring existing asthma medications for their potential in COPD treatment. Analysts anticipate that Dupixent's COPD approval could add up to $3.5 billion in peak sales, further boosting its already impressive revenue, which reached $11.6 billion last year, highlighting the drug's position as a leading treatment option in the respiratory market.