AstraZeneca Wins US FDA Priority Review for Hypophosphatasia Therapy

MT Newswires · 2d ago
02:43 AM EDT, 09/18/2026 (MT Newswires) -- AstraZeneca (AZN.L, AZN.ST) unit Alexion said Friday the US Food and Drug Administration granted priority review to its application for efzimfotase alfa to treat hypophosphatasia in patients aged two years or older. The biologics license application is backed by a late-stage clinical program comprising the Hickory, Mulberry and Chestnut studies, in which efzimfotase alfa showed favorable safety and tolerability profiles across all trials. The Prescription Drug User Fee Act action date is expected during the first half of 2027.