BRIEF—US Priority Review awarded for Crysvita

USA-based Ultragenyx and Japan’s Kyowa Kirin have announced that the US regulator has given Priority Review designation for a bid to broaden the label for Crysvita (burosumab).

Following initial approval in FGF23-related hypophosphatemic rickets and osteomalacia, the firms are looking to market the option for FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (TIO).

The US Food and Drug Administration has given an action date for a decision on the application of June 18, 2020.