Posted by Michael Wonder on 27 Feb 2020
Ultragenyx and Kyowa Kirin announce FDA acceptance and priority review designation of supplemental biologics license application for Crysvita (burosumab) for tumour-induced osteomalacia
27 February 2020 - Ultragenyx Pharmaceutical and Kyowa Kirin Co today announced that the U.S. FDA has accepted for review the supplemental biologics license application for Crysvita (burosumab) for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumours (tumour-induced osteomalacia; TIO) that cannot be curatively resected or localised.
The FDA has assigned priority review designation with a Prescription Drug User Fee Act target date of 18 June 2020.
