HYPERION trial results support earlier Winrevair use
Merck won a U.S. label update for PAH drug Winrevair to add Phase 3 HYPERION efficacy and safety results.
HYPERION results have already been presented via the updated label, supporting use soon after diagnosis alongside standard background therapy.
The trial showed Winrevair cut the likelihood of clinical worsening versus placebo in recently diagnosed adults with intermediate-to-high progression risk.
The label update adds safety language on hypersensitivity risk, monitoring for higher hemoglobin, lower platelets, bleeding, and thromboembolic events.
The disclosure broadens Winrevair’s clinical positioning earlier in the treatment pathway, reinforcing its role as an add-on option in PAH.
MRK•
