Sanofi's Avalglucosidase Alfa Therapy Granted Priority Review by FDA
November 18 2020 - 1:54AM
Dow Jones News
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 olivia.bugault@wsj.com
(END) Dow Jones Newswires
November 18, 2020 01:39 ET (06:39 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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