Tuesday, July 16, 2024

Merck’s WINREVAIR for Pulmonary Arterial Hypertension Receives Positive EU CHMP Opinion

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Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of WINREVAIR™ (sotatercept) for treating pulmonary arterial hypertension (PAH) in adults. This positive opinion is a crucial step towards expanding access to this new treatment in Europe.

If approved by the European Commission (EC), WINREVAIR will be the first activin signaling inhibitor therapy for PAH in Europe, providing a new option for adults with this progressive disease. The EC’s decision is expected in the third quarter of 2024. WINREVAIR has been granted Priority Medicines (PRIME) and orphan designation by the EMA, emphasizing its potential impact.

The CHMP recommendation is based on data from the Phase 3 STELLAR trial, which demonstrated significant improvements in exercise capacity and reduced risk of death or PAH clinical worsening events. These results, published in The New England Journal of Medicine, highlight WINREVAIR’s efficacy as part of a combination therapy for pulmonary arterial hypertension.

Merck’s WINREVAIR Gains Positive CHMP Opinion for Pulmonary Arterial Hypertension Treatment

WINREVAIR is administered once every three weeks as a single subcutaneous injection, which can be managed by patients or caregivers under healthcare provider supervision. The safety profile includes potential increases in hemoglobin and decreases in platelet count, necessitating regular monitoring. Common side effects include headache, epistaxis, rash, and dizziness.

Merck is committed to making WINREVAIR accessible globally, reflecting its dedication to patients with pulmonary arterial hypertension. This positive CHMP opinion supports Merck’s focus on expanding treatment options and improving patient outcomes. WINREVAIR’s approval by the U.S. FDA in March 2024 further underscores its potential in treating PAH.

The STELLAR study (NCT04576988) was a global, double-blind, placebo-controlled trial involving 323 PAH patients. The study showed significant improvements in exercise capacity and reduced risk of death or clinical worsening. Participants included idiopathic, heritable, and connective tissue disease-associated pulmonary arterial hypertension patients, with most receiving two or three background PAH therapies.

Pulmonary Arterial Hypertension

FDA-Approved WINREVAIR Enhances Exercise Capacity and Reduces Pulmonary Arterial Hypertension Worsening

WINREVAIR (sotatercept-csrk) is an FDA-approved activin signaling inhibitor for pulmonary arterial hypertension, improving exercise capacity and reducing clinical worsening events. It balances pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. The drug is licensed by Bristol Myers Squibb and shows promise in reversing right ventricular remodeling and improving hemodynamics. WINREVAIR may cause erythrocytosis, increasing the risk of thromboembolic events. Monitoring hemoglobin levels is essential. It may also cause thrombocytopenia, increasing bleeding risk. Serious bleeding and thrombocytopenia have been reported, especially in patients on prostacyclin therapy or antithrombotic agents.

Merck, known as MSD outside the U.S. and Canada, is dedicated to using leading-edge science to improve lives globally. With over 130 years of innovation, Merck continues to develop crucial medicines and vaccines. The company emphasizes diversity, sustainability, and responsible operation to create a healthier future for all.

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This release includes forward-looking statements about WINREVAIR’s potential benefits and regulatory progress. These statements are based on current expectations and are subject to risks and uncertainties. Merck’s future results may differ due to various factors, including industry conditions, competition, economic factors, and regulatory changes. For detailed risk information, refer to Merck’s filings with the Securities and Exchange Commission.

 

Resource: Merck, June 28, 2024

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