Dupixent's COPD Expansion Delayed in US, Nears EU Approval

The FDA has extended its review period for Sanofi and Regeneron’s Dupixent (dupilumab) by three months, moving the decision date to September 27. This extension was anticipated after Regeneron disclosed that the FDA had requested additional data to support the drug’s application for the treatment of chronic obstructive pulmonary disease (COPD) in patients with type 2 inflammation. Specifically, the FDA asked for more efficacy analyses from the BOREAS and NOTUS trials, as well as more detailed information on certain subpopulations.

Sanofi stated that the FDA determined the additional analyses submitted in May to be a significant amendment to the marketing application. Consequently, this led to the extension of the target action date from the original June 27 deadline. Leonard Schleifer, CEO of Regeneron, previously noted that their analyses indicated a consistent and clinically meaningful reduction in COPD exacerbations across the requested patient subgroups. Both Sanofi and Regeneron have clarified that the FDA has not expressed any concerns about the potential approval of Dupixent for COPD.

In a separate development, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Friday, recommending the approval of Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils. This indication is also under review in China.

Dupixent works by inhibiting the signalling pathways of IL-4 and IL-13. In the previous year, the drug generated sales amounting to €10.7 billion ($11.6 billion).

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