NICE recommends sotatercept for pulmonary arterial hypertension
Brian Attwood | May 20, 2026 | News story | | NICE, Winrevair, pulmonary arterial hypertension, sotatercept
The National Institute for Health and Care Excellence (NICE) has recommended Winrevair (sotatercept) as a treatment option for adults with pulmonary arterial hypertension (PAH), offering eligible patients in England a new therapy for the progressive condition.
PAH is a rare form of pulmonary hypertension caused by narrowing and thickening of the pulmonary arteries, that increases pressure on the heart and reduces oxygen delivery around the body. Symptoms can include shortness of breath, fatigue, dizziness and chest pain, and the condition can lead to frequent hospitalisation and shorter life expectancy.
It is estimated that 4,269 people in the UK are living with PAH, with an estimated 568 new diagnoses each year.
Sotatercept is an activin signalling inhibitor designed to target vascular remodelling in PAH by trapping proteins involved in abnormal blood vessel growth. NICE’s recommendation introduces a treatment with a different mechanism of action in an area where treatment options have remained limited.
Dr Iain Armstrong, Chair of PHA UK, said: “This is a significant moment for the PAH community. More patients will now have access to an important new therapy.”
The recommendation was based primarily on data from the phase 3 STELLAR trial, which enrolled 323 adults with PAH receiving stable background therapy. The study’s primary endpoint measured change in six-minute walk distance after 24 weeks.
Patients receiving sotatercept improved their walking distance by a median of 34.4m, compared with 1m in the placebo group.
Serious adverse events related to treatment were reported in 1.2% of both treatment groups. Common adverse events associated with sotatercept included bleeding and thrombocytopenia.
Jasveen Chugh, Executive Director and Head of Pharmaceutical Medicines in for MSD (the name used by Merck & Co. outside North America) in the UK, called the NICE recommendation “a significant milestone” for patients living with a condition where survival outcomes have seen limited improvement over the past decade.
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