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EU Approves Crysvita for Infants with XLH
22 Jul
Summary
- Crysvita now approved for infants as young as one month in the EU.
- Expanded approval extends orphan market exclusivity until February 2030.
- Clinical trial data supported the efficacy and safety in infants.
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 throughout the EU and European Economic Area. This regulatory action permits healthcare professionals to consider Crysvita for younger patients diagnosed with XLH.
This rare genetic disorder, XLH, is known to impact skeletal development in infancy and childhood, characterized by phosphate wasting. Clinical data supporting the expanded approval came from the Phase I/II open-label multi-centre BUR-CL207 trial, which assessed burosumab's efficacy, safety, tolerability, and pharmacokinetics in paediatric patients from birth to one year.
The safety profile observed in infants matched that already established for burosumab. This approval also qualifies Crysvita for an additional two years of orphan market exclusivity in the EU for XLH, extending regulatory protection until February 2030. Crysvita is reimbursed in various European countries for both paediatric and adult XLH populations.
