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NICE recommends WINREVAIR (Sotatercept) as a treatment option for adult patients in England and Wales with pulmonary arterial hypertension (PAH)

May 14, 2026 – Biotechnology, Clinical Trials, Other, Pharmaceutical – MSD, Merck, NICE recommendation, cardiology, pulmonary arterial hypertension

Sotatercept is indicated for use in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II to III, to improve exercise capacity
NICE has recommended sotatercept for adult patients living with PAH, if treatment is started when the person’s PAH is at intermediate–low risk at follow up after initial treatment for PAH, or if treatment is continued if their PAH progresses to intermediate–high risk
4,269 people live with PAH in the UK, and there are 568 new diagnoses each year. PAH results in the thickening and stiffening of the pulmonary arteries, placing greater strain on the heart and leading to breathlessness, extreme tiredness, chest pain, greater risk of heart failure and reduced life expectancy.

14 May 2026 — London, UK — MSD today welcomes news that, following an evidence submission, the National Institute for Health and Care Excellence (NICE) has recommended the use of WINREVAIR (sotatercept) as a treatment option for adult patients with pulmonary arterial hypertension (PAH).

PAH, a rare, severe and progressive form of pulmonary hypertension, which is characterised by high blood pressure in the blood vessels which supply the lungs, known as the pulmonary arteries. PAH causes the walls of these arteries to become thick and stiff – a process called vascular remodelling – narrowing the space through which blood is able to pass and increasing blood pressure and strain on the heart.

This results in the heart having to work harder to pump blood to the lungs, damaging the heart and reducing the efficiency with which blood and oxygen is delivered to the body. This results in debilitating symptoms including shortness of breath, fatigue, dizziness and feeling faint, and chest pain. PAH is a progressive illness, meaning it tends to get worse over time if it is not effectively treated. This also means that people with PAH are at an increased risk of frequent hospitalisations, other illnesses such as pneumonia, heart failure, and reduced life expectancy.

There are 4,269 people living with PAH in the UK, and there are 568 new diagnoses each year. Prior to today’s NICE decision, treatment options for PAH have included symptom control, treatments to slow disease progression and reverse heart and lung damage, and surgical interventions to reduce pressure on the heart or to transplant the heart or lungs.

According to trial leads from the STELLAR clinical trial, upon which NICE’s decision has been primarily based, current treatment options when administered either alone or in combination have resulted in a median survival of 5 to 7 years following diagnosis. However, no substantial improvements in survival have been realised over the past decade.

Sotatercept works by a novel mechanism, called an activin signalling inhibitor, which prevents the thickening and narrowing of small blood vessels in the lungs. This works by trapping activins – a protein that promotes cell growth and contributes to the vascular remodelling caused by PAH. As a result, NICE’s approval of sotatercept introduces a new treatment option in a space where there has been limited progress and considerable unmet need.

Dr Iain Armstrong, PHA UK Chair, said: “This is a significant moment for the PAH community. More patients will now have access to an important new therapy, and the approval matters because it was earned. Our members shared their experiences, their evidence, and their determination and that found its way into the formal process when it was needed most. But I want to be clear: a positive NICE recommendation is not the end of the road. It is the beginning of the next stage. Access on paper must become access in practice and that requires sustained, active work.”

Jasveen Chugh, Executive Director and Head of Pharmaceutical Medicines at MSD in the UK, said: “Today’s decision is fantastic news for eligible patients living with PAH and their families, marking a significant milestone in the treatment of this complex and life‑limiting condition. MSD has worked tirelessly to enable access to this innovative treatment option, and we are proud to support progress in an area of high unmet need. We remain committed to working with the NHS and the clinical community to ensure patients can access this treatment where appropriate.”

NICE’s approval was based primarily on data from the STELLAR Phase III trial, a multicentre, double-blind trial which investigated sotatercept for the treatment of PAH. The trial randomised 323 adults with PAH in a 1:1 ration to receive sotatercept (163 patients) or a placebo (160 patients), both in combination with stable background therapy.

The primary end point of the trial was the change from baseline at week 24 in the 6-minute walk distance, meaning the trial examined the change in how far each patient could walk for 6 minutes after 24 weeks. The median change from baseline at week 24 in the 6-minute walk distance was 34.4 m (95% confidence interval [CI], 33.0 to 35.5) in the sotatercept group and 1.0 m (95% CI, −0.3 to 3.5) in the placebo group. This means that the patients who were receiving sotatercept walked an average of 34 metres farther after 24 weeks, compared to an average of 1 metre in the placebo group.

Serious adverse events (SAEs) related to sotatercept or placebo were observed in 1.2% of both the sotatercept and placebo groups. The most common adverse events (AEs) of interest were bleeding events (21.5% in the sotatercept group and 12.5% of the placebo group), and thrombocytopenia [low blood platelet count] (6.1% of the sotatercept group and 2.5% of the placebo group).

Data from STELLAR demonstrated a safety profile for sotatercept which was generally consistent with that reported in previous studies. AEs were reported in 84.7% of the sotatercept group, compared to 87.5% of the placebo group.

About MSD
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd-uk.com.