FDA Approves Merck’s Winrevair for Pulmonary Arterial Hypertension
March 28, 2024
The U.S. Food and Drug Administration (FDA) recently approved Winrevair, a new treatment developed by pharmaceutical giant Merck for adults suffering from pulmonary arterial hypertension (PAH). This approval introduces a novel therapy option for the estimated 40,000 PAH patients in the U.S., aiming to significantly impact a disease characterized by a daunting five-year mortality rate of 43%.
Winrevair, also known by its chemical name etanercept, distinguishes itself as the inaugural drug of its kind to receive FDA approval, targeting activin proteins involved in the disease’s arterial constriction. PAH is marked by narrowed arteries in the lungs, escalating blood pressure and leading to symptoms like shortness of breath, chest pain, and dizziness, ultimately straining the heart to the brink of failure.
Jannie Oosthuizen, president of Merck’s U.S. Human Health business, expressed optimism about the drug’s potential to alter the treatment landscape for PAH patients. She highlighted the list price of $14,000 per vial. Given the recommended usage of one vial every three weeks, a patient’s annual cost would be approximately $238,000.
The drug’s market debut is anticipated by the end of April, following Merck’s acquisition of Acceleron Pharma in 2021 for $11.5 billion. This move is part of Merck’s strategic initiative to bolster its cardiovascular drug portfolio, particularly as it prepares for the impact of biosimilars on Keytruda, its leading cancer therapy.
Winrevair’s approval was underpinned by a 24-week Phase III trial involving 323 PAH patients. Those administered the drug exhibited notable improvement in exercise capacity, specifically a 40.8-meter increase in their six-minute walking distance compared to placebo recipients.
Analysts, including J.P. Morgan’s Chris Schott, predict a strong market entry for Winrevair. They forecast it to quickly integrate into the standard care regimen for eligible PAH patients and achieve peak sales nearing $5 billion by 2030. This development marks a significant stride in addressing the urgent needs of those battling pulmonary arterial hypertension.
To read more, click here.
[Source: Reuters, March 27th, 2024]
