John Reed (Endpoints JPM19, Jeff Rumans)
Analysts poured cold water, but FDA gives a fast-pass for Sanofi's new Pompe disease drug
Analysts didn’t love the results from Sanofi’s pivotal Pompe disease study, but the FDA has evidently seen enough promise to give it an expedited look.
On Wednesday, the French giant announced that the agency has given priority review for their Pompe disease drug avalglucosidase alfa, handing them a PDUFA data for May 18 and a chance to get a further head start on Amicus and the rival drug now in Phase III.
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