Positive results from a study of Winrevair could help the drugmaker achieve sales growth past top-seller Keytruda’s upcoming patent expirations this decade.

Published Nov. 25, 2024

Jonathan GardnerSenior Reporter

Merck announced on Nov. 25, 2024, that its pulmonary arterial hypertension drug Winrevair succeeded in a clinical trial. Marko Georgiev / Stringer via Getty Images

Dive Brief:

• Adding Merck & Co.’s new cardiovascular drug Winrevair to background therapy helped people with severe lung hypertension stay alive and avoid invasive medical care longer than those who only received background therapy, the company said Monday.
• Data from the ZENITH trial could potentially expand use of a drug that’s now forecast to earn $5 billion a year at its peak. A trial steering committee stopped the trial early at an interim checkpoint because data indicated the Winrevair combination clearly outperformed placebo, Merck said.
• Merck obtained Winrevair in 2021 with its $11 billion acquisition of Acceleron in 2021. The pharmaceutical company is looking for sales of heart disease drugs to drive growth in coming years as its biggest seller, the cancer treatment Keytruda, loses market exclusivity later in the decade.

Dive Insight:

Winrevair treats pulmonary arterial hypertension, a condition that makes pumping blood through the lungs harder and eventually causes heart damage. Patients can have a range of symptoms, from shortness of breath while doing everyday activities, to fatigue, discomfort and even shortness of breath while at rest. Life expectancy in individuals who experience the latter symptom is very short — about one year.

Pulmonary hypertension has a range of therapies, including types of drugs used to treat heart failure. It is also treated with drugs specific to the condition, such as Johnson & Johnson’s blockbusters Opsumit and Uptravi, which J&J obtained when it bought Actelion for $30 billion in 2017.

Winrevair won Food and Drug Administration approval earlier this year based on study data showing it improved walking speed in people with the disorder, a functional measure that was the trial’s primary goal. Treatment also delayed death and other complications. That study was in moderately ill people who had slight or moderate impairment due to their condition.

The ZENITH study announced Monday tested Winrevair in people with the most severe disease classification, along with those who are moderately impaired. Investigators assessed all-cause death, lung transplantation or any disease-related hospitalization as the study’s main measure. Those outcomes measures are important for doctors and insurers to know how well patients will fare over the long term while taking the drug.

Merck didn’t release detailed data from the study but will present them at an upcoming medical meeting and to regulators.

“This is the first study in [pulmonary arterial hypertension] in which the interim analysis led to an early conclusion of the study due to overwhelming efficacy,” said Vallerie McLaughlin, director of the pulmonary hypertension program at the University of Michigan and a paid Merck consultant, in a statement. “Winrevair has brought significant optimism to the field, and we thank the investigators and patients for being part of this important study.”

In a client note, Evercore ISI analyst Umer Raffat wrote that the study confirms Winrevair’s “incredible efficacy,” but noted data from a trial in heart disease expected in 2025 will be a more important catalyst as it could “expand target population by many-fold.”

Winrevair earned sales of $219 million through Sept. 30.