European Commission approves Winrevair to treat PAH in adults
Decision follows medication's US approval in March for PAH
Winrevair (sotatercept-csrk), Merck’s injection therapy for adults with pulmonary arterial hypertension (PAH), has been approved in the European Union, as well as in Iceland, Liechtenstein, and Norway.
The approval from the European Commission specifically covers Winrevair when used in combination with other PAH therapies to improve exercise capacity in PAH patients with World Health Organization (WHO) functional class 2 or 3.
The decision follows a positive opinion recently issued by the Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency, which recommended the use of Winrevair for this indication. Winrevair was also recently approved by the U.S. Food and Drug Administration for PAH.
“We are proud to bring this innovative treatment to more patients and remain committed to further investigating the potential of Winrevair in areas where there are unmet needs in the management of PAH,” Joerg Koglin, MD, PhD, senior vice president and head of general medicine, global clinical development at Merck Research Laboratories, said in a company press release. Merck is known as MSD outside of the United States and Canada.
PAH is a type of pulmonary hypertension characterized by high blood pressure in the pulmonary arteries, which are the blood vessels that transport blood from the heart to the lungs. This is caused by a narrowing of the pulmonary arteries that is driven by the abnormal growth of the endothelial cells that line their walls. This, in turn, is driven by the action of signaling molecules called growth factors.
‘Devastating disease for patients’
“Pulmonary arterial hypertension is a devastating disease for patients, who suffer from debilitating symptoms that can severely limit their daily activities,” said Marc Humbert, MD, PhD, director of the Pulmonary Hypertension Reference Center at Université Paris-Saclay. “New treatment opinions continue to be needed for patients.”
Winrevair’s active ingredient is a fragment of a growth factor receptor that acts as a trap for excess growth factors, thereby reducing cell growth. The treatment is given once every three weeks by subcutaneous (under-the-skin) injection, and may be administered by patients or caregivers who have received proper training.
The therapy’s approval in Europe was supported by data from the Phase 3 STELLAR trial (NCT04576988) which enrolled 323 PAH patients who were randomly assigned to receive Winrevair, starting at a dose of 0.3 mg/kg and up to 0.7 mg/kg, or a placebo, in addition to standard treatments, for about six months.
After six months, Winrevair led to a significant increase in the distance walked in six minutes, a common measure of exercise capacity, relative to the placebo (mean of 40.8 meters or about 134 feet).
Also, a higher proportion of patients on Winrevair experienced an improvement in WHO functional class than those receiving the placebo (29% vs. 14%).
Treatment can reduce risk of clinical worsening or death by 82%
The treatment also reduced the risk of clinical worsening or death by 82% compared with standard therapy alone.
In addition, Winrevair was shown to improve measures of heart health and blood flow, and was predicted to extend patient survival by more than a decade.
The most commonly reported adverse events included headache, nose bleeds, skin redness and rash, dilated veins under the skin, diarrhea, and dizziness.
“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,” Humbert said.
Winrevair was previously granted orphan drug and priority medicines designations by the European Medicines Agency for PAH.
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