Posted by Michael Wonder on 11 Oct 2017
Ultragenyx and Kyowa Hakko Kirin announce FDA acceptance and priority review designation of burosumab's biologics license application
10 October 2017 - Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International today announce that the U.S. FDA has accepted the biologics license application for burosumab to treat paediatric and adult patients with X-linked hypophosphataemia and has granted priority review status.
Burosumab previously received breakthrough therapy designation from the FDA for the treatment of X-linked hypophosphataemia in paediatric patients one year of age and older.
The Prescription Drug User Fee Act action date for the BLA is 17 April 2018.
