FDA approves treatment for tumor-induced osteomalacia
The U.S. Food and Drug Administration (FDA) has approved burosumab (Crysvita) for the treatment of tumor-induced osteomalacia (TIO).
Burosumab is indicated for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in TIO associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older.
“For approximately half of all individuals with TIO, surgical removal of the tumors is not possible, leaving these patients with no other treatment options. The FDA approval of Crysvita marks the first treatment option that addresses the cause of the severe hypophosphatemia and osteomalacia resulting from these rare tumors,” said Camille L. Bedrosian, MD, Chief Medical Officer of Ultragenyx, in a press release. “We plan to leverage our experience and existing infrastructure with Crysvita in X-linked hypophosphatemia to bring this important medicine to patients living with the rare, painful and debilitating disorder of TIO.”
Read the full press release here.