Kyowa Kirin subsidiary Kyowa Kirin EMEA has received approval from the European Commission (EC) to expand the use of Crysvita (burosumab) for treating X-linked hypophosphataemia (XLH) in infants aged one month to one year across the EU and European Economic Area.
The announcement follows a positive recommendation issued in April 2026 by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
This regulatory action permits healthcare professionals to consider Crysvita for younger patients with XLH, a rare and progressive genetic disorder known to impact skeletal development in infancy and childhood.
XLH is characterised by phosphate wasting, which disrupts bone mineralisation and can result in skeletal deformities, impaired growth, and additional complications.
Clinical data supporting the expanded approval come from the Phase I/II open-label multi-centre BUR-CL207 trial, which assessed the efficacy, safety, tolerability, and pharmacokinetics of burosumab in paediatric patients from birth to one year.
The company reported that the safety profile observed in infants matched that already established for burosumab.
Kyowa Kirin EMEA regional franchise head Myriam Hakim said: “This approval means healthcare professionals can now consider treatment with burosumab from as young as one month of age, creating an opportunity to address the disease earlier than ever before. It represents an important step forward for infants living with XLH and the families who care for them."
The approval further qualifies the therapy for an additional two years of orphan market exclusivity in the EU for XLH, extending regulatory protection until February 2030.
Burosumab is a recombinant human monoclonal antibody that binds to the protein fibroblast growth factor 23 (FGF23), aiding in the regulation of phosphate levels in the body.
It is reimbursed in various European countries, including France, Germany, Italy, Spain and the UK, for both paediatric and adult XLH populations.
In May 2026, Kyowa Kirin received approval from the US Food and Drug Administration for a dosing update to the prescribing information for Crysvita, introducing a new option for adults with XLH.
