FDA Grants Approval to Merck’s Therapy for Rare Lung Condition

158

The U.S. Food and Drug Administration (FDA) has granted approval for Merck’s treatment, Winrevair, designed for adults suffering from high blood pressure caused by constriction of the lung arteries. This approval marks a significant addition to Merck’s pharmaceutical portfolio, potentially opening doors to substantial revenue growth for the company. In response to the news, Merck’s shares surged by more than 4% in extended trading.

Winrevair, indicated for the treatment of pulmonary arterial hypertension (PAH), addresses a condition affecting around 40,000 individuals in the United States alone. Jannie Oosthuizen, president of Merck’s U.S. Human Health business, emphasized the potential impact of the drug on patients facing a disease with a high mortality rate, citing a five-year mortality rate of 43% for PAH patients.

The therapy Winrevair is expected to be priced at $14,000 per vial, with most patients likely requiring a single vial every three weeks. Based on trial data, this translates to an annual cost of $238,000 per patient. Merck anticipates bringing the drug to market by the end of April.

Merck gained the rights to Winrevair through its acquisition of Acceleron Pharma for $11.5 billion in 2021. The company has been strategically bolstering its cardiovascular drug portfolio to mitigate potential revenue declines from biosimilar competition to its blockbuster cancer treatment, Keytruda.

Winrevair, chemically known as sotatercept, represents the first treatment in its class of drugs to secure FDA approval. These drugs target a protein type called activin. PAH, characterized by arterial constriction in the lungs, leads to high blood pressure and symptoms like shortness of breath, chest pain, and dizziness. The condition also imposes additional strain on the heart, potentially leading to heart failure.

Analyst Chris Schott from J.P. Morgan predicts a robust initial launch for sotatercept, envisioning it quickly becoming a standard treatment option for eligible PAH patients. He estimates peak sales for the therapy to reach approximately $5 billion by 2030.

The FDA approval for Merck’s drug Winrevair was based on a 24-week-long late-stage trial involving 323 PAH patients. Results from the trial demonstrated a significant improvement in exercise capacity among patients treated with the drug, as evidenced by a 40.8-meter increase in their 6-minute walking distance compared to those receiving a placebo.