Clinical research conducted at UC Health and the University of Cincinnati College of Medicine played a role in the U.S. Food and Drug Administration (FDA)’s March 26 approval of WINREVAIR™ (sotatercept-csrk) for the treatment of pulmonary arterial hypertension (PAH) in adults.
Developed by Merck, WINREVAIR™ is a breakthrough biologic fusion protein that traps circulating activin and GDF proteins, the first and only FDA-approved therapy targeting this signaling mechanism in PAH. It represents a new class of therapy that works by rebalancing signaling to restore regulation of vascular cell proliferation, potentially reversing the vascular remodeling underlying PAH.
“We haven’t had a new pathway drug for PAH that’s shown promise in nearly a decade,” said Arun Jose, MD, Assistant Professor of Internal Medicine in the UC College of Medicine’s Division of Pulmonary, Critical Care and Sleep Medicine and a UC Health physician.
Pulmonary arterial hypertension is a vascular disease of the lungs that is chronic, progressive, and ultimately fatal. Many patients with PAH are on lifelong continuous infusion therapy administered via a pump that they must carry at all times. WINREVAIR™ will offer a new PAH therapy option and could not only improve their disease severity but also help significantly improve quality of life.
“Currently, our most aggressively-treated patients are on oral medications in addition to lifelong infusion therapy. Sotatercept was studied added on to our current PAH medications. It is a less burdensome drug as compared to some of our other PAH therapies, in that it’s a subcutaneous injection every three weeks,” said Jean Elwing, MD, Professor of Internal Medicine in the UC College of Medicine’s Division of Pulmonary, Critical Care and Sleep Medicine and Director of the Pulmonary Hypertension Program.
UC Health treats about 1,000 patients with pulmonary hypertension, including about 500 with pulmonary arterial hypertension. The health system plans to offer WINREVAIR™ to eligible PAH patients.
UC Health and the University of Cincinnati have been a leader in PAH for more than a decade: in 2014, they became one of the first five PAH-certified centers in the country. The center is involved in most clinical research for PAH nationally.
UC Health and the University of Cincinnati have also participated in the clinical trials that were pivotal in WINREVAIR™’s pathway to FDA approval, including the Phase 3 STELLAR trial and its open label extension SOTERIA.
The STELLAR Trial demonstrated that adding sotatercept to existing PAH therapies provided significant clinical benefits, improving patients’ hemodynamic disease severity, exercise capacity, symptoms, and quality of life.
“Across the board, it seems to have decreased the burden of pulmonary vascular disease in the treated patients,” Dr. Jose said.
Many of the PAH patients involved in the studies were already receiving maximum therapy under the current standard of care, and a lung transplant would have been the next option available to them.
UC Health and the University of Cincinnati are also involved in the ongoing HYPERION and ZENITH trials designed to better understand the benefits of sotatercept for patients at other stages of PAH.