FDA approves Crysvita for treating tumour-induced osteomalacia
pharmafile | June 19, 2020 | News story | Medical Communications | FDA, FDA approvals
The FDA has approved Crysvita (burosumabtwza) injection to treat patients over two years old with tumour-induced osteomalacia (TIO).
This is a rare disease characterized by the development of tumours that cause weakened and softened bones through releasing a peptide hormone-like substance known as FGF23 that lowers phosphate levels.
Two studies evaluated the safety and efficacy of Crysvita and tested 27 patients, where the participants received the injection every four weeks. In the first study, half of patients received normal phosphate levels through to week 24 and maintained normal or near normal phosphate levels through to week 144. The results of bone scans for patients suggested healing of the bone lesions related to TIO.
In the second study, 69% of participants achieved normal levels through to week 24, and maintained normal or near normal phosphate levels through to week 88.
Dr Theresa E. Kehoe, Acting Director of the Division of General Endocrinology, said: “Treatment for TIO focuses on identifying and removing the tumor that causes the disease. However, when that is not possible, Crysvita can help increase the levels of phosphate in the blood. As the first FDA-approved therapy to treat this debilitating disease, today’s action is an important step in finding treatment options for patients living with TIO whose tumor cannot be found or removed.”
Crysvita was previously approved by the FDA to treat adults and children with X-linked hypophosphatemia.
Conor Kavanagh
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