Merck's pulmonary arterial hypertension therapy receives CHMP recommendation

03 Jul 2024
pmlive.com
Merck's pulmonary arterial hypertension therapy receives CHMP recommendation
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Source: PMLiVE
Merck & Co – known as MSD outside of the US and Canada – has received a recommendation from the European Medicines Agency’s human medicines committee for the use of its pulmonary arterial hypertension (PAH) therapy in adults.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that Winrevair (sotatercept), in combination with other PAH therapies, be approved to improve exercise capacity in patients with World Health Organization functional classes two to three.
Approximately 30,000 people in the EU are currently living with PAH, a rare and progressive disorder in which the blood vessels in the lungs thicken and narrow. This blocks the blood flow through the lungs, which raises blood pressure and results in a significant strain on the heart.
Administered once every three weeks as a single injection, Winrevair works by improving the balance between pro-proliferative and anti-proliferative signalling to modulate vascular proliferation underlying PAH.
The CHMP’s decision on the therapy is supported by positive data from the late-stage STELLAR trial, which compared Winrevair to placebo, both taken in combination with background standard of care therapies in adult patients with PAH.
Results showed that the addition of Winrevair to background therapy led to a statistically significant and clinically meaningful improvement in six-minute walk distance, the study’s primary endpoint, and on multiple secondary outcome measures, including a reduction in the risk of death from any cause or PAH clinical worsening events.
Dr Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories, said: “There is still a significant need for new therapies for [PAH] patients.
“This positive opinion marks the first step toward expanding access to our first-in-class activin signalling inhibitor therapy, Winrevair, for eligible adults with PAH in Europe.”
The European Commission will now review the recommendation, with a final decision from the regulator expected in the third quarter of this year.
The opinion came less than two weeks after Merck received approval from the US Food and Drug Administration for its adult-specific 21-valent pneumococcal conjugate vaccine.
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