No advisory panel meeting planned for Ultragenyx's burosumab

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) said Wednesday that FDA does not plan to hold an advisory committee meeting to discuss a BLA for burosumab (KRN23, UX023) to treat X-linked hypophosphatemia (XLH) in adult and pediatric patients. The PDUFA date is April 17, 2018.

Last month, FDA accepted and granted Priority Review to the BLA. An MAA for the recombinant human IgG1 mAb against fibroblast growth factor 23 (FGF23) is under EMA review (see BioCentury Extra, Oct. 10)...