Global Finance News
22 Sep 2026, 18:23
FDA Updates Merck’s WINREVAIR Label With HYPERION Pulmonary Hypertension Data
Merck said the U.S. Food and Drug Administration approved an update to the label for WINREVAIR to include efficacy and safety data from the Phase 3 HYPERION trial in adults recently diagnosed with pulmonary arterial hypertension.
HYPERION enrolled patients diagnosed within the previous 12 months who were at intermediate to high risk of disease progression. Adding WINREVAIR to background therapy reduced the risk of clinical worsening events by 76% compared with placebo, with a hazard ratio of 0.24. A first clinical worsening event occurred in 10.6% of WINREVAIR-treated patients versus 36.9% of those receiving placebo.
The updated label provides additional evidence for using WINREVAIR earlier in the treatment pathway, rather than only later in the disease course. Most patients in HYPERION were already receiving double or triple background therapy, and the treatment effect was consistent across prespecified subgroups.
The FDA update also adds safety information from HYPERION. The most common adverse reactions included epistaxis, telangiectasia and increased hemoglobin, while treatment discontinuation due to adverse events occurred in 3% of WINREVAIR patients.
WINREVAIR is already approved for adults with pulmonary arterial hypertension to improve exercise capacity and functional class and reduce the risk of clinical worsening events. The new label strengthens Merck’s case for broader and earlier use of the drug in PAH care.
Merck said the U.S. Food and Drug Administration approved an update to the label for WINREVAIR to include efficacy and safety data from the Phase 3 HYPERION trial in adults recently diagnosed with pulmonary arterial hypertension.
HYPERION enrolled patients diagnosed within the previous 12 months who were at intermediate to high risk of disease progression. Adding WINREVAIR to background therapy reduced the risk of clinical worsening events by 76% compared with placebo, with a hazard ratio of 0.24. A first clinical worsening event occurred in 10.6% of WINREVAIR-treated patients versus 36.9% of those receiving placebo.
The updated label provides additional evidence for using WINREVAIR earlier in the treatment pathway, rather than only later in the disease course. Most patients in HYPERION were already receiving double or triple background therapy, and the treatment effect was consistent across prespecified subgroups.
The FDA update also adds safety information from HYPERION. The most common adverse reactions included epistaxis, telangiectasia and increased hemoglobin, while treatment discontinuation due to adverse events occurred in 3% of WINREVAIR patients.
WINREVAIR is already approved for adults with pulmonary arterial hypertension to improve exercise capacity and functional class and reduce the risk of clinical worsening events. The new label strengthens Merck’s case for broader and earlier use of the drug in PAH care.
