Regeneron, Sanofi Get FDA OK of Dupixent for COPD — Update

By Colin Kellaher

Regeneron Pharmaceuticals and Sanofi have won Food and Drug Administration expanded approval of their blockbuster anti-inflammatory drug Dupixent in treatment of chronic obstructive pulmonary disease.

Regeneron and Sanofi on Friday said the green light covers Dupixent as an add-on maintenance treatment in certain adults with uncontrolled chronic obstructive pulmonary disease, or COPD, and makes Dupixent the first U.S. biologic therapy for the lung disease, which makes it difficult to breathe.

European Union regulators in July approved Dupixent for COPD, and the companies earlier Friday said they received China regulatory approval for the additional indication.

In a research note, analysts at RBC Capital Markets said the FDA nod for Dupixent treatment in COPD includes as clean and favorable of a label as could have been hoped for and sets stage for significant medium-term uptake.

RBC said it sees an ultimate world-wide COPD sales opportunity topping $6.5 billion, bringing overall Dupixent sales to more than $26 billion at their peak.

Tarrytown, N.Y., biotechnology company Regeneron created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement, while Sanofi markets the product internationally. The drug generated roughly $11.6 billion in sales last year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 27, 2024 13:20 ET (17:20 GMT)

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