Posted by Michael Wonder on 14 Jan 2020
Ultragenyx and Kyowa Kirin announce submission of supplemental biologics license application to U.S. FDA for Crysvita (burosumab) for tumour-induced osteomalacia
13 January 2020 - Ultragenyx and Kyowa Kirin today announced that they submitted a supplemental biologics license application to the U.S. FDA on 18 December 2019, for Crysvita (burosumab) for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumour-induced osteomalacia) that cannot be curatively resected or localized.
The companies expect to hear back from the FDA on submission acceptance and review designation in February 2020.
The package includes data from two single-arm Phase 2 studies, a 144-week study in 14 adult patients conducted by Ultragenyx in the U.S. and an 88-week study in 13 adult patients conducted by Kyowa Kirin in Japan and South Korea.
