FDA clears expanded label for Crysvita

Ultragenyx Pharmaceutical (NASDAQ:RARE) and Kyowa Kirin Co., announces that the 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 pediatric patients with X-linked hypophosphatemia (XLH), 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.

Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23), indicated for the treatment XLH in adult and pediatric patients 6 months of age and older.

https://seekingalpha.com/news/3502574-fda-clears-expanded-label-crysvita