Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)

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• Merck looks forward to the EC's decision as they work to ensure broad patient access to the first and only activin signaling inhibitor therapy approved in Europe and continue to deliver meaningful evidence to support treatment decisions

  80% confidence

• WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation, and in preclinical models induced cellular changes associated with thinner vessel walls, partial reversal of right ventricular remodeling and improved hemodynamics

  80% confidence

• This broader indication would recognize the impact of WINREVAIR on morbidity and mortality in adult patients with PAH, extending the overall use of WINREVAIR to be inclusive of WHO FC II, III and now IV patients, with a treatment objective beyond the improvement of exercise capacity

  80% confidence

• Approximately 90,000 people worldwide are living with PAH, and the disease progresses rapidly for many patients with a five-year mortality rate of approximately 43%

  80% confidence

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