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Sanofi, Regeneron's Dupixent Receives Recommendation for Approval From European Medicines Agency Committee
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Sanofi, Regeneron's Dupixent Receives Recommendation for Approval From European Medicines Agency Committee
May 31, 2024 5:05 AM

07:32 AM EDT, 05/31/2024 (MT Newswires) -- The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of dupilumab, known as Dupixent, in the European Union as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease, Sanofi ( SNY ) said Friday.

Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) are jointly developing dupilumab under a global collaboration agreement.

The European Commission is expected to make a final decision on the Dupixent application in the coming months, Sanofi ( SNY ) said.

The committee's recommendation is based on the data from two phase 3 studies that met the primary endpoint.

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