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Ultragenyx, Kyowa file application for genetic disorder drug approval

Ultragenyx Pharmaceutical Inc. and Kyowa Hakko Kirin Co. Ltd. have filed for U.S. Food and Drug Administration approval for their burosumab treatment for a rare genetic disorder.

The regulator accepted the biologics license application for review as a treatment of pediatric and adult patients with X-linked hypophosphatemia with a target action date of April 17, 2018.

The drug previously received the breakthrough therapy designation for the treatment of XLH in pediatric patients one year of age and older. The drug also holds a rare pediatric disease designation.

In April, the companies reported positive results from the phase 3 trial of burosumab in adults with X-linked hypophosphatemia.