ARTICLE | Clinical News

Kyowa XLH therapy approved in EU

March 2, 2018 6:40 PM UTC

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the European Commission granted conditional approval to an MAA for Crysvita burosumab (KRN23, UX023) to treat X-linked hypophosphatemia with radiographic evidence of bone disease in children aged one and older, and in adolescents with growing skeletons.

Kyowa plans to launch Crysvita in Germany next quarter, followed by additional EU countries. Crysvita is a recombinant human IgG1 mAb against fibroblast growth factor 23 (FGF23)...