Winrevair - opinion on variation to marketing authorisation

Opinion

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

sotatercept

Opinion

On 11 September 2025, 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 Winrevair. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.

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

Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II to, III, and IV to improve exercise capacity (see section 5.1).

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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CHMP post-authorisation summary of positive opinion for Winrevair (EMA/VR/0000278021)

Adopted Reference Number: EMADOC-1700519818-2692693

Key facts

• Name of medicine:
  Winrevair
• EMA product number:
  EMEA/H/C/005647
• Active substance:
  sotatercept
• International non-proprietary name (INN) or common name:
  sotatercept
• Therapeutic area (MeSH):
  Hypertension, Pulmonary
• Anatomical therapeutical chemical (ATC) code:
  C02KX06
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• 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.

• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.
• Date of opinion:
  11/12/2025
• Status:
  Positive