04:49 AM EDT, 05/31/2024 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) said Friday the US Food and Drug Administration has extended until Sept. 27 the action date on the biologics license application for Dupixent as a supplemental maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease.

The three-month extension comes after the FDA earlier requested additional analyses of the efficacy of the drug, also known as dupilumab, with the additional information constituting a major amendment to the application.

Regeneron and Sanofi ( SNY ) said they are confident that the additional analyses will support the approval of Dupixent as a treatment for the requested indications.

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