EU approves Kyowa Kirin’s Crysvita for infants with XLH

PUBT · 3d ago
EU approves Kyowa Kirin’s Crysvita for infants with XLH
  • European Commission cleared Crysvita (burosumab) to treat X-linked hypophosphataemia in infants aged 1 month to 1 year across the EU, EEA.
  • Label expansion widens the drug’s addressable population, enabling earlier treatment in a rare pediatric bone disease.
  • Decision follows a positive CHMP opinion in April 2026.
  • Ruling triggers a two-year extension of EU orphan market exclusivity for XLH to February 2030.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Kyowa Kirin Co. Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 202607210300BIZWIRE_USPR_____20260721_BW637293) on July 21, 2026, and is solely responsible for the information contained therein.