Winrevair

Opinion

EMA has issued an opinion on this medicine

Sotatercept

Overview

On 27 June 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Winrevair², intended for the treatment of pulmonary arterial hypertension (PAH). The applicant for this medicinal product is Merck Sharp & Dohme B.V.

Winrevair will be available as 45 mg and 60 mg powder and solvent for solution for injection and 45 mg and 60 mg powder for solution for injection. The active substance of Winrevair is sotatercept, an antihypertensive for pulmonary arterial hypertension (ATC code: C02KX06). Sotatercept is a human recombinant fusion protein. It acts as a ligand trap that scavenges excess Activin A, which is increased in PAH patients, to inhibit activin signalling thereby modulating vascular cell proliferation, decreasing pulmonary vascular resistance and improving haemodynamics.

The benefit of Winrevair in patients with PAH on background therapy is an improvement in 6-minute walk distance (6MWD) compared with placebo, as observed in a randomised, double-blind, placebo-controlled study. Sotatercept was generally well-tolerated and had a manageable safety profile; however, treatment was associated with increased haemoglobin (erythrocytosis) and a decreased platelet count (thrombocytopenia), both of which were manageable by dose modification. The most common side effects are headache and nosebleeds.

The full indication is:

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, to improve exercise capacity.

Winrevair should be prescribed by physicians experienced in the diagnosis and treatment of PAH.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

---

²This product was designated as an orphan medicine during its development.  EMA will now review the information available to date to determine if the orphan designation can be maintained

CHMP initial authorisation summary of positive opinion for Winrevair

AdoptedReference Number: EMA/CHMP/289588/2024

Product details

• Name of medicine:
  Winrevair
• Active substance:
  sotatercept
• International non-proprietary name (INN) or common name:
  Sotatercept
• Therapeutic area (MeSH):
  Hypertension, Pulmonary
• Anatomical therapeutic chemical (ATC) code:
  C02KC06
• EMA product number:
  EMEA/H/C/005647
• 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 applicant:
  Merck Sharp & Dohme B.V.
• Opinion adopted:
  27/06/2024
• Opinion status:
  Positive