24 August 2017 - Ultragenyx and Kyowa Hakko Kirin today announced that Ultragenyx has submitted a biologics license application with the FDA for burosumab to treat X-Linked Hypophosphatemia (XLH) in the US. 

Burosumab has previously received breakthrough therapy designation from the FDA for the treatment of XLH in paediatric patients one year of age and older.

The FDA will evaluate the submission and will decide on whether to accept it within 60 days, at which time the Prescription Drug User Fee Act action date will be set.

Read Ultragenyx press release