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Last Friday, the Medicines and Healthcare Products Regulatory Agency approved Merck & Co Inc’s (NYSE:MRK) Winrevair (sotatercept) for adult patients with pulmonary arterial hypertension (PAH).
Sotatercept is used, in combination with other medicines, to treat PAH in adults with moderate or marked physical activity limitations and improve exercise capacity.
The recommended dosing schedule is one injection every three weeks via self-administration.
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In March 2024, the FDA approved Winrevair (sotatercept-csrk), for injection, 45mg, 60mg for adults with PAH to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.
A main study was conducted involving 323 patients with PAH. The study showed that sotatercept was more effective than placebo at improving the ability of adults with PAH to exercise. The main measure of effectiveness was the difference in the distance patients could walk in 6 minutes before and after treatment.
After 24 weeks of treatment, sotatercept given in addition to other PAH medicines, improved the distance patients could walk in 6 minutes by around 34 meters, compared with 1 meter in patients who received a placebo instead. The median (average) treatment difference between the sotatercept and placebo groups was 40.8 meters.
In November, Merck revealed topline results from the Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality.
ZENITH met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours).
Price Action: MRK stock is up 0.56% at $100.04 at last check Thursday.
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Image via Merck
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