Regeneron Pharmaceuticals, Sanofi Say FDA Accepts Application for Skin Disease Treatment

MT Newswires Live11-15 17:25

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) said Friday the US Food and Drug Administration has accepted for review a resubmission of the supplemental biologics license application for Dupixent as a potential treatment for patients aged 12 years and older with chronic spontaneous urticaria.

Chronic spontaneous urticaria is an inflammatory skin disease that causes debilitating hives and recurring itch.

The FDA target action date for a decision on the drug, also known as dupilumab, is April 18.

The resubmitted application is supported by newly added results from a phase 3 clinical trial of Dupixent which showed the drug "significantly reduced" itch and hives generated by the illness, the companies said.

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