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Last Friday, the Pharmaceutical and Health Products Administration approved Merck MRK Winrevair (sotatercept) is used in adult patients with pulmonary arterial hypertension (PAH).

Sotatercept is used in combination with other medications to treat PAH and improve exercise capacity in adults with moderate or significant physical activity limitations.

The recommended dosing schedule is self-administered injections every three weeks.

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In March 2024, the FDA approved Winrevair (sotatercept-csrk), injection, 45 mg, 60 mg, for use in adults with PAH to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical deterioration events.

One major study involved 323 patients with PAH. Studies have shown that sotatercept is more effective than placebo in improving exercise capacity in adults with PAH. The primary measure of efficacy was the difference in distance patients walked within 6 minutes before and after treatment.

After 24 weeks of treatment, patients given sotatercept in addition to other PAH drugs increased the distance they could walk in 6 minutes by approximately 34 meters, compared with an increase of only 1 meter in patients receiving placebo. The median (mean) treatment difference between the sotatercept and placebo groups was 40.8 meters.

In November, Merck announced top results from the ZENITH Phase 3 study, which evaluated Winrevair (sotatercept-csrk) in adult patients with pulmonary arterial hypertension (PAH, WHO group 1) functional class (FC) III or IV who are at high risk of death. therapeutic effect.

ZENITH met its primary endpoint of first morbidity or mortality event (all-cause death, lung transplantation, or hospitalization related to PAH exacerbation ≥ 24 hours).

Price Action: MRK shares were up 0.56% at $100.04 as of check Thursday.

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Image via Merck