Ultragenyx Pharmaceutical Submits License Application

Ultragenyx Pharmaceutical has submitted a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) for burosumab to treat X-Linked Hypophosphatemia (XLH). Burosumab has previously received breakthrough therapy designation from the FDA for the treatment of XLH in pediatric patients one year of age and older. The FDA will evaluate the submission and will decide on whether to accept it within 60 days.

Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International PLC, a wholly owned subsidiary of Kyowa Hakko Kirin, have been collaborating in development and commercialization of burosumab globally based on the collaboration and license agreement between Kyowa Hakko Kirin and Ultragenyx.