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EU grants conditional approval for Kyowa Hakko, Ultragenyx genetic disorder drug

Kyowa Hakko Kirin Co. Ltd. said the European Commission granted conditional approval for Crysvita in treating a rare musculoskeletal disorder which is characterized by low phosphate levels in the blood.

Crysvita, or burosumab, is meant to treat X-linked hypophosphatemia, or XLH, in children that are at least 1 year old.

In December 2017, the European Commission's Committee for Medicinal Products for Human Use recommended the conditional approval of the drug based on positive data from clinical trials.

A conditional approval is usually granted when a medicine addresses unmet medical needs of patients on the basis of less comprehensive data than normally required.

The Tokyo-based life pharmaceutical company expects to commercially launch the treatment in Germany in the second quarter, followed by other European countries.

Kyowa Hakko and Ultragenyx Pharmaceutical Inc., a Novato, Calif.-based biopharmaceutical company, are collaborating in the development and commercialization of the drug.