Winrevair likely to be available soon in US via CVS, Accredo: Merck
Therapy for adults works to improve exercise capacity, prevent PAH worsening
Note: This story was updated April 11, 2024, to remove reference to Acceleron Pharma, now a wholly owned subsidiary of Merck.
Winrevair (sotatercept-csrk), the under-the-skin injectable treatment recently approved in the U.S. for adults with pulmonary arterial hypertension (PAH), is expected to be available for dispensing at CVS and Accredo pharmacies by late April, Merck reports.
Winrevair’s distribution network will continue to be evaluated after its commercial launch, a Merck spokesperson said in a written Q&A with Pulmonary Hypertension News.
Winrevair binds to and traps activins, proteins that trigger the growth of the endothelial cells that line blood vessels. In PAH, this cell layer keeps growing, narrowing the blood vessels that supply the lungs. As a result, the heart is forced to work harder to pump blood to the lungs.
By trapping activins, Winrevair works to prevent them from sending signals to cells. This is expected to lessen the abnormal cell growth that drives PAH progression and makes it increasingly difficult for patients to breathe, affecting their ability to exercise.
Winrevair, an injection PAH treatment, may be given at home with training
In STELLAR (NCT04576988), the Phase 3 clinical trial that supported Winrevair’s approval, the medication was shown to improve exercise capacity over six months, with patients on Winrevair being able to walk farther than those on a placebo. It also helped to improve WHO functional class and to reduce a patient’s risk of death or clinical worsening.
As a first approved PAH treatment that’s a biologic medicine — meaning it’s made or derived from living organisms — “Winrevair has the potential to make a meaningful difference for appropriate patients,” said Mahesh Patel, MD, vice president of global clinical development at Merck Research Laboratories.
Given once every three weeks “on top of stable background therapy,” Patel added, Winrevair “provided clinically and statistically meaningful improvements beyond background therapy alone on multiple important outcome measures.”
Winrevair is intended for use in the clinic under the guidance of a healthcare provider, but it may be administered at the home by patients or their caregivers, once they are given proper training by a provider.
At-home treatment with Winrevair is possible after “guidance, training and follow-up from the healthcare provider on how to reconstitute, prepare, measure and inject” the therapy, said the spokesperson for Merck, which is known as MSD outside of North America.
In addition to assistance provided through the Merck Access Program, providers and patients can request further nursing support. More information can be found by visiting www.merckaccessprogram-winrevair.com or calling 888-637-2502.
CVS and Accredo, selected as specialty pharmacies to dispense Winrevair initially, currently support patients on other medications approved to treat PAH. “This approach will help support a seamless experience for patients,” the spokesperson said.
Clinical trials assessing therapy’s long-term benefits, potential in children
An ongoing and open-label study, called SOTERIA (NCT04796337), is looking into how safe Winrevair is and how well it works when given to adults with PAH, on top of background therapy, for longer than four years.
An interim analyses of trial data covering more than 400 patients showed Winrevair to be well tolerated, with sustained benefits over one year. Almost 20% of patients experienced serious treatment-emergent side effects — either a side effect onset or worsening during treatment — but only 1.5% needed to stop treatment.
“The estimated primary completion date [for SOTERIA] is September 2027,” Patel said, adding that Merck looks forward “to continuing to share [trial] results as they become available.”
Two other ongoing Phase 3 clinical trials, ZENITH (NCT04896008) and HYPERION (NCT04811092), “are evaluating Winrevair in patients with more advanced disease and those earlier in their disease journey,” Patel said.
While Winrevair is approved in the U.S. for adult patients, it also is being tested in MOONBEAM (NCT05587712) in children and adolescents with PAH, ages 1 to 17. This open-label Phase 2 study currently is recruiting patients at sites across the U.S., Europe, Australia, and elsewhere.
MOONBEAM, which is evaluating the biologic therapy’s safety and tolerability over about six months of use, is expected to conclude in 2028.
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