FDA approves FGF23 blocking antibody Crysvita for tumor-induced osteosesasapha (TIO)

Ultragenyx Pharmaceuticals and Kyowa Kirin incannounced that the U.SFood and Drug AdministrationAdministration (
FDA) has approved its fibroblast growth factor 23 (FGF23) blocking antibody Crysvita (burosumab) for the treatment of tumor-induced ostlated (TIO) tumor-induced bone softening (TIO) in adult andchildren over 2 years of age andchildren with low phosphorusCrysvita is a recombinant, human-sourced single-clone IgG1 antibody that blocks the activity of FGF23FGF23 is a hormone that reduces blood phosphorus and active vitamin D levels by regulating the release and activity of phosphatesin the kidneys and the production of vitamin D" For about half of TIO patients, it is not possible to surgically remove the tumor, leaving these patients with no other treatment optionsThe FDA's approval of Crysvita marks the first treatment option that could be used for rare tumors that cause severe hypophospha and osteosese," said Camille LBedrosian, Chief Medical Officer of UltragenyxTIO is a rare disease, usually caused by benign, slow-growing tumors that produce excess FGF23Patients with TIO may experience severe hypophosphonosis (low levels of phosphate in the blood), softening (softening of bones), muscle weakness, fatigue, bone pain, and fractures Current treatments include oral phosphates or active vitamin D substitutes, but the efficacy is limited this is the second FDA-approved Crysvita to develop a second form of indications, having previously been approved for the first time in April 2018 for the treatment of patients with X-chain hypophostic emis (XLH) patients aged 1 and older