Ultragenyx: FDA Review On Burosumab BLA Proceeding According To Review Timelines

(RTTNews) - Ultragenyx Pharmaceutical Inc. (RARE), Kyowa Hakko Kirin Co., Ltd. and Kyowa Kirin International plc announced the U.S. FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss the Biologics License Application for burosumab to treat pediatric and adult patients with X-Linked Hypophosphatemia. The FDA indicated that the review is proceeding according to its internal review timelines.

The FDA previously granted burosumab Priority Review status. The PDUFA action date for the Biologics License Application is April 17, 2018.