Sanofi's Dupixent Drug Review Date Extended by Three Months in the U.S.

By Ian Walker

French pharmaceutical company Sanofi said that the priority review date in the U.S. for its chronic obstructive pulmonary disease treatment, Dupixent, but stressed that there weren't any concerns over the drug.

The U.S. Food and Drug Administration asked for more information from recent trials of Dupixent, and said that the extra data constitutes a major amendment to the supplemental biologics license application. It has therefore extended the date for its review to Sept. 27.

"Sanofi and Regeneron are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation, and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible," the companies said.

Sanofi and Regeneron are jointly developing Dupixent under a global collaboration agreement.

Separately, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Dupixent for European Union approval.

The EU is expected to announce a final decision on the Dupixent application in the coming months.

Write to Ian Walker at ian.walker@wsj.com

(END) Dow Jones Newswires

May 31, 2024 01:49 ET (05:49 GMT)

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