Posted by Michael Wonder on 01 Oct 2019
Ultragenyx and Kyowa Kirin announce U.S. FDA approves label update for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia
30 September 2019 - Expanded label includes additional clinical data highlighting superiority over conventional therapy for paediatric patients and extends current U.S. indication to patients aged six months and older.
Ultragenyx Pharmaceutical and Kyowa Kirin today announced that the U.S. FDA has approved a label expansion for Crysvita (burosumab).
The label has been updated to include new clinical data demonstrating superiority of treatment with Crysvita versus oral phosphate and active vitamin D (conventional therapy) in paediatric patients with XLH, and improvement in stiffness, and maintenance of efficacy of Crysvita in adult patients with longer-term treatment. The indication has also been expanded to include infants as young as six months of age.
