2 October 2020 - More people in Europe are now eligible for treatment with Crysvita, the only therapy that targets the underlying pathophysiology of X-linked hypophosphataemia, a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints.

Kyowa Kirin today announced that the European Commission has approved Crysvita (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphataemia.

The application to expand the marketing authorisation was based on data from two Phase 3 studies: the Phase 3 UX023-CL303 study, a randomised, double-blind, placebo-controlled trial investigating the safety and efficacy of burosumab in adults with XLH, and the Phase 3 UX023-CL304 study, an open-label, single-arm study investigating the effects of burosumab on osteomalacia (softening of the bones) in adults with X-linked hypophosphataemia.

Read Kyowa Hakko Kirin press release