European approval for Crysvita for treatment of XLH in children
Japan’s Kyowa Hakko Kirin (TYO: 4151) and US biotech Ultragenyx Pharmaceutical (Nasdaq: RARE) today announced that Crysvita (burosumab) has received a positive European Commission decision granting a conditional marketing authorization to Kyowa Kirin for the treatment of X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children one 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.
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