AstraZeneca Wins FDA Priority Review for Rare Bone Disease Drug

03:51 AM EDT, 09/18/2026 (MT Newswires) -- AstraZeneca (AZN) said Friday the US Food and Drug Administration granted priority review to its Alexion unit's biologics license application for efzimfotase alfa to treat patients aged two years and older with hypophosphatasia, a genetic bone disorder. The health regulator is expected to make a regulatory decision in H1 2027, and the filing is supported by results from three phase 3 trials in children and adults, the company said. The proposed biweekly treatment is designed to address skeletal abnormalities and functional issues associated with the disorder, AstraZeneca said.