European Marketing Authorisation for Crysvita® for treatment of XLH

Kyowa Kirin and Ultragenyx Announce Crysvita® (burosumab) Receives Conditional Marketing Authorisation in Europe for the Treatment of X–Linked Hypophosphatemia in Children


Kyowa Hakko Kirin Co. Ltd, Kyowa Kirin International PLC and Ultragenyx Pharmaceutical Inc. has announced that Crysvita® (burosumab) has received a positive European Commission decision granting a conditional marketing authorisation to Kyowa Kirin for the treatment of X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons. XLH is a rare, chronic progressive musculoskeletal disorder that affects children and adults.

This is the first regulatory approval globally for Crysvita, an anti-FGF23 fully human monoclonal antibody that is the first treatment to target the underlying pathophysiology of XLH. The European Medicines Agency recently acknowledged Crysvita as an outstanding contribution to public health and a significant improvement in the endocrinology therapeutic area.

The European Marketing Authorisation is valid in the 28 countries of the European Union and in Norway, Iceland and Liechtenstein. The first commercial launch of Crysvita is expected to take place in Germany in the second quarter of 2018, followed by other European countries.

“XLH is extremely debilitating to patients and this authorisation in Europe provides children with the first treatment option that addresses the excess FGF23 activity in XLH,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. “Through this authorisation and our work throughout the rest of the world we are committed to bringing Crysvita to all patients with XLH who could benefit from the therapy.”


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