Amarin stands behind Vascepa after new analysis raises questions about its efficacy

Even as Amarin's Vascepa is under siege from generics in the U.S., a new analysis raises questions about the company's key cardiovascular drug.

After Amarin's drug won a coveted FDA label expansion in 2019 to cut cardiovascular risks in certain patients, the company funded another analysis of its phase 3 REDUCE-IT study. In the new analysis, researchers found minimal changes in certain blood biomarkers for patients being treated with Vascepa after 12 and 24 months.

The pill is approved to lower blood triglyceride levels and cardiovascular risks in certain high-risk patients. In the phase 3 trial, researchers compared Vascepa, or icosapent ethyl, with a mineral oil placebo.

In the trial, Vascepa achieved a 25% risk reduction for major adverse cardiovascular events compared with placebo. Investigators recorded a 31% risk reduction for heart attacks, 28% for strokes and 20% for cardiovascular deaths, respectively.

But in the new post-hoc study, researchers noted that the biomarker differences between the two groups of patients appear to reflect a worsening among the mineral oil patents rather than a benefit for Vascepa patients.

"Among participants in REDUCE-IT, allocation to [Vascepa] had minimal effects on a series of biomarkers associated with atherosclerotic disease, whereas levels increased among those allocated to mineral oil," the team wrote. Still, the researchers said it's "uncertain" how the findings affect the drug's overall efficacy profile.

Amarin is standing behind the medicine.

“What is most clear and important clinically are the cardiovascular outcomes results seen in the REDUCE-IT trial overall,” Nabil Abadir, chief medical officer of Amarin, said in a statement.

Meanwhile, Amarin has recently had to downsize in the U.S. after the company was hit by an early generic launch in the key market. Since the company's coveted label expansion for Vascepa, Amarin's stock price has fallen from more than $20 in late 2019 to $1.32 on Friday.