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WINREVAIR is the first and only activin signaling inhibitor1-12

The imbalance of ActRIIA-BMPRII signaling underlying PAH results in:

  • Vascular cell hyperproliferation causing
  • Pathological remodeling of the pulmonary arterial wall,
  • Narrowing of the arterial lumen,
  • Increasing PVR, and leads to
  • Increased pulmonary artery pressure (PAP) and right ventricular (RV) dysfunction.

In rat models of PAH, a sotatercept analog:

  • Reduced expression of proinflammatory markers at the pulmonary arterial wall,
  • Reduced leukocyte recruitment,
  • Inhibited proliferation of endothelial and smooth muscle cells, and
  • Promoted apoptosis in diseased vasculature.

These cellular changes were associated with thinner vessel walls, reversed arterial and RV remodeling, and improved hemodynamics.


In PAH clinical studies, WINREVAIR decreased PVR
and reversed RV remodeling


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References:
1. Hoeper MM, Badesch DB, Ghofrani HA, et al; STELLAR Trial Investigators. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490. 2. Merck receives priority review from FDA for new biologics license application for sotatercept, an activin signaling inhibitor to treat adults with pulmonary arterial hypertension (PAH). News release. Merck. September 28, 2023. Accessed February 16, 2024. https://www.merck.com/news/merck-receives-priority-review-from-fda-for-new-biologics-license-application-for-sotatercept-an-activin-signaling-inhibitor-to-treat-adults-with-pulmonary-arterial-hypertension-pah/ 3. Treposuvi. Summary of Product Characteristics. AOP Orphan Ltd; 2023. 4. Adempas. Summary of Product Characteristics. Bayer AG; 2023. 5. Ventavis. Summary of Product Characteristics. Bayer AG; 2023. 6. Adcirca. Summary of Product Characteristics. Eli Lilly Nederland BV; 2023. 7. Volibris. Summary of Product Characteristics. GlaxoSmithKline (Ireland) Limited; 2021. 8. Opsumit. Summary of Product Characteristics. Janssen-Cilag International NV; 2023. 9. Tracleer. Summary of Product Characteristics. Janssen-Cilag International NV; 2023. 10. Uptravi. Summary of Product Characteristics. Janssen-Cilag International NV; 2022. 11. Flolan. Summary of product characteristics, labelling and package leaflet. EMA; 2012. 12. Revatio. Summary of Product Characteristics. Upjohn EESV; 2023. 13. Humbert M, McLaughlin V, Gibbs SR, et al. Sotatercept for the treatment of pulmonary arterial hypertension. N Engl J Med. 2021;384:1204-1215.