Merck has received approval from the European Commission for Winrevair to treat patients with pulmonary arterial hypertension (PAH).
The therapeutic can now be administered to adult patients in the functional classes II and III, and can be used in combination with other PAH therapies.
Winrevair — otherwise called sotatercept, is the first activin inhibitor therapy for PAH.
The drug is now approved for use in 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.
The European Commission’s decision is based off of the results of the Phase III STELLAR trial, which demonstrated the favourable efficacy and safety profile of Winrevair.
“Pulmonary arterial hypertension is a devastating disease for patients, who suffer from debilitating symptoms that can severely limit their daily activities,” said Dr Marc Humbert, Professor of Medicine and Director of the Pulmonary Hypertension Reference Center at Université Paris-Saclay.
“New treatment opinions continue to be needed for patients. Based on the Phase III STELLAR study, adding WINREVAIR to background PAH therapy improved exercise capacity, reduced the risk of death or clinical worsening events and improved functional class compared to background PAH therapy alone. These findings are significant and reinforce that WINREVAIR, in combination with other PAH therapies, should be considered as a new standard of care for the treatment of functional class II and III adult patients.”
Winrevair should be administered tri-weekly as a single injection under the skin, and may be administered by patients or caregivers with guidance and training from a healthcare professional.