Merck/MSD announced today that the Phase 3 HYPERION trial on pulmonary arterial hypertension patients (Group 1 World Health Organisation) in functional class II-III was suspended. Patients in the study will be offered the option of receiving WINREVAIR through the Phase 3 SOTERIA open-label extension study.
Findings from the HYPERION study will be available later this year and presented at a future medical congress.
WINREVAIR is currently approved in the U.S. and 38 countries based on the results from the Phase 3 STELLAR trial.
Reminder: the Phase 3 ZENITH trial on patients with pulmonary arterial hypertension patients in functional class III-IV, was also suspended last year, for the same reasons, see here for further details
This is the link to the press release
