EC expands Crysvita approval to infants with rare phosphate disorder
The European Commission has approved an expanded indication for Japan-based pharma company Kyowa Kirin’s (TYO: 4151) Crysvita (burosumab), allowing the medicine to be used in infants from one month to under one year of age with X-linked hypophosphatemia (XLH).
This decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in April 2026 and extends the use of the fibroblast growth factor 23 (FGF23)-targeting monoclonal antibody in the European Union (EU).
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