The US Food and Drug Administration (FDA) has granted approval to Merck & Co (MSD)’s sotatercept-csrk, known by the brand name WINREVAIR, for the treatment of adults with pulmonary arterial hypertension (PAH).
It is the first FDA-approved activin-signalling inhibitor therapy for PAH.
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By GlobalDataPAH is a rare progressive and life-threatening disease in which blood vessels in the lungs narrow and thicken, leading to a huge strain on the heart.
The treatment is indicated for use in PAH patients to improve exercise capacity, enhance WHO functional class and decrease the likelihood of worsening clinical events.
The therapy, which had already received breakthrough therapy designation from the FDA, works by re-instating the balance between pro and anti-proliferative signalling to regulate the vascular cell proliferation linked to PAH.
WINREVAIR is administered as a subcutaneous injection every three weeks.
The latest approval is based on results from the STELLAR trial, a global, double-blind, placebo-controlled, multicentre, parallel-group Phase III study.
It involved 323 adult patients and examined the effects of WINREVAIR compared to placebo, both given along with standard background therapies.
There was a significant 41m improvement in the six-minute walk distance from the baseline at week 24 when WINREVAIR was added to background therapy.
The treatment also substantially improved several secondary outcome measures, notably reducing mortality or PAH clinical worsening event risks by 84% compared to background therapy alone.
The company will make WINREVAIR available through select speciality pharmacies in the US by the end of next month.
Merck Research Laboratories global clinical development senior vice-president, head and chief medical officer Dr Eliav Barr stated: “PAH remains a debilitating disease with high morbidity and mortality.
“This approval of WINREVAIR is an important milestone and a testament to our science-led strategy and focus on the development of innovations that can help people affected by rare diseases like PAH.”
Earlier this month, MSD completed the acquisition of Harpoon Therapeutics to bolster its oncology pipeline.
