WINREVAIR (sotatercept-csrk)
Recently diagnosed pulmonary arterial hypertension · Adults with recently diagnosed pulmonary arterial hypertension receiving background therapy
MRK · Merck
Full timeline
4 milestonesFDA approved the WINREVAIR HYPERION label update
FDA approved an update to the U.S. WINREVAIR label to include efficacy and safety data from HYPERION in adults with PAH diagnosed within the previous 12 months who were receiving background therapy.
Merck — FDA approval of the WINREVAIR HYPERION label update↗FDA accepted the sBLA
FDA accepted the supplemental application seeking to update the U.S. label based on the Phase 3 HYPERION trial.
Merck — Fourth-quarter 2025 results and regulatory update↗HYPERION met its primary endpoint
WINREVAIR reduced the risk of clinical-worsening events by 76% versus placebo in adults with recently diagnosed PAH receiving background therapy.
Merck — Positive Phase 3 HYPERION results↗Phase 3 HYPERION study started
The event-driven HYPERION trial began evaluating sotatercept in adults diagnosed with pulmonary arterial hypertension within the prior year.
ClinicalTrials.gov — HYPERION study record (NCT04811092)↗Related News
No related news available.