Crysvita - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

burosumab

Opinion

On 23 April 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Crysvita. The marketing authorisation holder for this medicinal product isKyowa Kirin Holdings B.V.

The CHMP adopted an extension to the existing indication as follows:

Crysvita is indicated for the treatment of X-linked hypophosphataemia in infants from 1 month to 1 year of age with hypophosphataemia (see section 5.1), in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.

Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Crysvita (VR-0000263400)

Adopted Reference Number: EMADOC-1700519818-3044024

Key facts

• Name of medicine:
  Crysvita
• EMA product number:
  EMEA/H/C/004275
• Active substance:
  burosumab
• International non-proprietary name (INN) or common name:
  burosumab
• Therapeutic area (MeSH):
  • Hypophosphatemia, Familial
  • Hypophosphatemic Rickets, X-Linked Dominant
  • Osteomalacia
• Anatomical therapeutical chemical (ATC) code:
  M05BX05
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Kyowa Kirin Holdings B.V.
• Date of opinion:
  23/04/2026
• Status:
  Positive