Merck (MRK) said Tuesday that the FDA approved an update to the US label for WINREVAIR, or sotatercept-csrk, based on data from the Phase 3 HYPERION trial in adults with pulmonary arterial hypertension diagnosed within the prior 12 months.

The updated label includes efficacy and safety data for patients with newly diagnosed PAH who received WINREVAIR in addition to background therapy, it said.

In HYPERION, WINREVAIR reduced the risk of clinical worsening events by 76% versus placebo, with a hazard ratio of 0.24, it added.

The study enrolled adults with WHO functional class II or III PAH who were at intermediate to high risk of disease progression.

The update also includes additional safety information and monitoring recommendations for hemoglobin and platelet levels, Merck said.