Sanofi's Avalglucosidase Alfa Therapy Granted Priority Review by FDA

   By Olivia Bugault 
 

Sanofi SA said Wednesday that the U.S. Food and Drug Administration has granted priority review for enzyme therapy avalglucosidase alfa.

The long-term replacement therapy is for the treatment of patients with Pompe disease, a rare degenerative muscle disorder that can affect an individual's ability to move and breathe, the company said.

"Avalglucosidase alfa is an investigational enzyme replacement therapy designed to improve the delivery of acid alpha-glucosidase enzyme to muscle cells, and if approved, would offer a potential new standard of care for patients with Pompe disease," the company said.

The pharmaceutical giant said it submitted the therapy to the FDA based on positive data from two trials, and avalglucosidase alfa has already received the FDA breakthrough-therapy and fast-track designations.

The target action date for the FDA decision is May 18, 2021, Sanofi said.

Write to Olivia Bugault at [e-mail]

(END) Dow Jones Newswires

November 18, 2020 01:39 ET (06:39 GMT)

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