The FDA has approved an update to the label for Merck’s Winrevair, adding Phase 3 HYPERION trial data in adults recently diagnosed with pulmonary arterial hypertension, or PAH.
Winrevair, or sotatercept-csrk, is approved for adults with World Health Organization Group 1 PAH to improve exercise capacity and functional class and reduce clinical-worsening events, including PAH hospitalization, lung transplantation and death.
HYPERION enrolled 320 adults with WHO functional class II or III PAH diagnosed within 12 months of screening and assessed as being at intermediate to high risk of disease progression. Participants were randomized equally to Winrevair or placebo, administered subcutaneously every three weeks on top of background PAH therapy.
Adding Winrevair reduced the risk of clinical worsening events by 76% versus placebo, Merck said. The hazard ratio was 0.24, with a 95% confidence interval of 0.14 to 0.41 and a p-value below 0.0001.
A first clinical-worsening event occurred in 17 of 160 patients, or 10.6%, receiving Winrevair, compared with 59 of 160 patients, or 36.9%, receiving placebo. The composite primary endpoint included death, unplanned PAH-related hospitalization of at least 24 hours, atrial septostomy, lung transplantation, or a decline in six-minute walk distance combined with other indicators of worsening disease.
Participants had been diagnosed with PAH for a mean of 7.2 months. Seventy-two percent received dual background therapy, while 28% received triple therapy. Seventeen percent received prostacyclin infusion therapy.
The most common adverse reactions in HYPERION were nosebleeds, reported in 31.9% of Winrevair patients and 6.9% of placebo patients; telangiectasia, 26.3% and 11.3%; and increased hemoglobin, 11.3% and 1.3%, respectively. Three percent of Winrevair patients discontinued treatment because of an adverse event, compared with none in the placebo group.
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