FDA Postpones Dupixent COPD Decision; EU Panel Approves

Regeneron announced on Friday that the U.S. Food and Drug Administration (FDA) has postponed its priority review of a supplemental Biologics License Application (sBLA) for Dupixent, an antibody used to treat uncontrolled chronic obstructive pulmonary disease (COPD). The delay comes as Dupixent nears its approval in the European Union.

The FDA has extended the review period by three months, moving the Prescription Drug User Fee Act (PDUFA) target action date to September 27, 2024. While no concerns were raised about the drug's potential approval, the agency has requested additional analyses on the drug's efficacy based on data from the Phase III Boreas and Notus trials. This addition was deemed a "major amendment" to the sBLA, necessitating the extension from the original target date of June 27, 2024.

Analysts from Bank of Montreal Capital Markets suggested that this delay would likely have a minor negative impact on Regeneron's stock. They emphasized that the delay is not due to any efficacy issues with Dupixent in treating COPD and expressed confidence in eventual approval due to the robust data from the Boreas and Notus trials.

In parallel, Regeneron also received positive news from European regulators. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion on Dupixent, recommending its use as an add-on treatment for adults with uncontrolled COPD. The European Commission is expected to finalize its decision in the coming months.

The CHMP's recommendation is based on the Phase III Boreas and Notus trials. The Boreas trial, reported in March 2023, met all primary and secondary endpoints, showing a significant reduction in moderate or severe COPD exacerbations. Specifically, Dupixent use led to a 30% reduction in such exacerbations over 52 weeks. The Notus trial, which presented its results in May 2024, evaluated Dupixent as an add-on maintenance therapy and found a 34% reduction in exacerbations over 52 weeks, with a p-value of 0.001.

Dupixent has been a significant revenue generator for both Regeneron and its partner Sanofi. In the first quarter of 2024, the drug generated $3.08 billion in sales, which, although slightly under analyst expectations, represented a 24% increase from the first quarter of 2023.

The recent developments highlight the ongoing journey of Dupixent toward broader approval and market penetration, particularly in the treatment of COPD. The additional analyses requested by the FDA and the positive CHMP opinion position the drug for potential success in both the U.S. and European markets.