FDA Approves Ultragenyx Pharmaceuticals’ Crysvita for Rare Bone Disease

The FDA has approved Ultragenyx Pharmaceuticals’ Crysvita (burosumab-twza) for patients aged two and older with tumor-induced osteomalacia, a disease characterized by tumors that cause weakened and softened bones.

The approval makes the fibroblast growth factor 23 (FGF23) blocking antibody the first treatment approved for the disease.

Crysvita is also approved to treat X-linked hypophosphatemia, which causes low levels of phosphate in the blood and can impair bone growth in children and teenagers.