Kyowa Kirin EMEA, a subsidiary of Japanese pharmaceutical company Kyowa Kirin Co Ltd (TSE:4151), said on Tuesday that the European Commission has approved an expanded indication for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia (XLH) in infants aged one month to one year across the European Union and European Economic Area.

This decision broadens access to earlier treatment for the rare, progressive genetic disease, which can affect skeletal development from infancy.

The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in April 2026 and is supported by data from the Phase 1/2 BUR-CL207 study in patients from birth to one year of age. The study found the safety profile in infants was consistent with the established safety profile of burosumab.

The expanded indication also extends Crysvita's orphan market exclusivity for XLH in the European Union by two years, from February 2028 to February 2030.