FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EC Approves Kyowa Kirin and Ultragenyx’s Treatment for XLH

March 1, 2018
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The European Commission granted Crysvita (burosumab) a conditional marketing authorization for the treatment of X-linked hypophosphatemia (XLH), a rare bone disorder in children and adolescents with growing skeletons.

Crysvita is the first treatment that targets the underlying pathophysiology of XLH, a chronic, progressive musculoskeletal disorder that causes skeletal disease in children. The authorization marks the product’s first regulatory approval globally.

“We will now focus our efforts on working with health authorities to ensure patient access in European countries,” said Tom Stratford, president and CEO of Kyowa Kirin, the drug’s co-sponsor with Ultragenyx.

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