Kyowa Kirin EMEA has won European Commission approval to expand Crysvita (burosumab) for infants aged one month to one year with X‑linked hypophosphataemia (XLH). The decision, following a positive CHMP opinion in April 2026, is supported by Phase I/II BUR‑CL207 data showing a safety profile in infants consistent with older patients. The approval also extends Crysvita's orphan exclusivity in the EU until February 2030.
European Commission Approves Crysvita for Infants (1 Month–1 Year) With X‑Linked Hypophosphataemia
The trial assessed burosumab in paediatric patients from birth to one year. Credit: Inara Prusakova / Shutterstock.com.
Kyowa Kirin EMEA has received European Commission (EC) approval to expand the label for Crysvita (burosumab) to include infants aged one month to one year across the European Union and the European Economic Area for the treatment of X‑linked hypophosphataemia (XLH).
Regulatory Background
The EC decision follows a favourable opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued in April 2026. The extension allows clinicians in EU and EEA countries to consider burosumab earlier in life for infants diagnosed with XLH, a rare genetic disorder that disrupts bone mineralisation during infancy and childhood.
Supporting Evidence
The approval is supported by data from the Phase I/II open‑label, multi‑centre BUR‑CL207 trial, which evaluated efficacy, safety, tolerability and pharmacokinetics of burosumab in paediatric patients from birth to one year of age. Kyowa Kirin reported that the safety profile observed in the infant cohort was consistent with previously established safety data for burosumab in older children and adults.
Myriam Hakim, Regional Franchise Head, Kyowa Kirin EMEA: "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."
Clinical and Market Implications
Burosumab is a recombinant human monoclonal antibody that targets fibroblast growth factor 23 (FGF23), helping to restore phosphate regulation and support bone mineralisation. The EC decision also grants Crysvita an additional two years of orphan market exclusivity in the EU for XLH, extending regulatory protection until February 2030.
Crysvita is reimbursed for paediatric and adult XLH populations in several European countries, including France, Germany, Italy, Spain and the United Kingdom. Separately, in May 2026 Kyowa Kirin received approval from the US Food and Drug Administration (FDA) for a dosing update to Crysvita's prescribing information that introduces a new dosing option for adults with XLH.
What This Means For Families and Clinicians
The earlier treatment option may allow clinicians to intervene during critical periods of skeletal development, potentially reducing the severity of deformities and improving growth outcomes. As always, treatment decisions should be individualized and guided by clinical judgement and local reimbursement policies.
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