Merck's New Drug Miraculously Helps 323 Patients with Lung Disease

The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced on Tuesday the approval of a new drug developed by Merck for the treatment of a rare lung disease. This approval further solidifies the pharmaceutical company’s success in the potential blockbuster product sector.

The drug, named sotaterept, was previously approved in the US in March 2024 and is marketed under the brand name Winrevair. It has also received approval in the EU and over 30 other markets.
The MHRA's approval is based on research data involving 323 patients with pulmonary arterial hypertension. In this study, sotaterept demonstrated significantly better effects on improving patients' exercise capacity compared to a placebo.

The development of sotaterept is part of Merck's acquisition of Acceleron Pharma for $11.5 billion in 2021. Through this acquisition, Merck obtained sotaterept and has been expanding its cardiovascular drug portfolio to address potential sales impacts from the expiration of patents on its bestselling cancer treatment Keytruda by the end of the century.

Regulators noted that sotaterept can be used to treat adult patients with moderate to significant physical activity limitations to help improve their exercise capacity. The recommended dosing schedule is a self-injection every three weeks.

According to the National Health Service (NHS) data, there were 9,263 active pulmonary arterial hypertension patients in the UK as of March 2024. Pulmonary arterial hypertension refers to elevated blood pressure in the vessels supplying blood to the lungs, making it more difficult for the heart to pump blood and potentially leading to organ failure.

Sotaterept works by targeting the activation protein, which plays a key role in pulmonary artery narrowing. Since its launch in March, Winrevair has achieved $149 million in sales. According to data compiled by LSEG, analysts expect its sales to exceed $1 billion by 2025. In the US, the therapy is priced at $14,000 per vial.

Merck has not yet responded to inquiries from reporters regarding the pricing and availability of the therapy in the UK.