Amarin’s Vascepa nabs ADA backing to cut heart risks, even ahead of FDA review

The cardiovascular outcomes results Amarin rolled out for its fish oil-derived Vascepa may not have impressed all, but at least one leading health organization in the U.S. is ready to throw its weight behind the drug, even before an FDA review of the label expansion.

The American Diabetes Association (ADA) on Wednesday said its 2019 treatment guidelines recommend Vascepa for diabetes and atherosclerotic cardiovascular disease patients with high triglyceride levels to lower heart risks.

ADA based its decision on the Reduce-It trial, which showed that Vascepa, when given to patients already on statin therapies, could cut the risk of major adverse CV events. The recommendation is listed in the association's 2019 edition of the Standards of Medical Care in Diabetes.

The Reduce-It data isn’t without its controversies, however. Back in November, when Amarin announced the drug had cut the risk of a first major CV event—including CV-related death, heart attack and stroke, among others—by 25% versus placebo, critics said the dummy pill used in the study negatively affected results in the control group and in turn boosted Vascepa’s effectiveness profile.

Just last week at the American College of Cardiology annual meeting, Amarin unveiled new data from the same Reduce-It study, showing Vascepa reduced the risk of total CV events by 30% compared with placebo at a median follow-up of 4.9 years.

In its own recommendation, ADA gave the trial a level "A" grade, which by ADA definition means the scientific evidence comes from "large well-designed clinical trials or well-done meta-analyses," and therefore is of the highest quality.

"Generally, these recommendations have the best chance of improving outcomes when applied to the population to which they are appropriate," ADA said in its guideline.

Backing from the ADA will of course reach physicians on the ground, saving Amarin some effort to raise awareness within the medical community. In a Wednesday note to investors, Jefferies analyst Michael Yee said the guideline change represents "an incremental tailwind as the landmark data […] is likely to continue to drive strong script growth throughout the year."

Vascepa reached $77.3 million in sales in the fourth quarter, up 44% year over year, thanks at least in part to prescriptions driven by the Reduce-It results, the company said. And current prescription trends suggest first-quarter sales could land between $80 million to $85 million, easily beating consensus of $67 million, even though Amarin itself has predicted lower first-quarter sales due to seasonal effects.

As for the whole of 2019, Yee expects Vascepa sales could come in north of Amarin’s guidance of around $350 million.  

The company has started transferring the Reduce-It data to the FDA as part of its label expansion bid, hoping to finish submission by the end of March. Yee said he expects a standard 10-month review with a decision date in late 2019 or early 2020.

Skeptics have argued that Amarin's trial design—namely the control arm—will spark some controversy if and when it comes up for advisory committee discussion, but Yee predicts a clean approval, which now seems more likely with ADA’s recommendation.

On Amarin’s fourth-quarter conference call, CEO John Thero said an FDA expert panel review would not necessarily be a negative, as the FDA might use the opportunity to emphasize the difference between prescription therapy and dietary supplements. Vascepa, an FDA-approved drug, is a purified form of the omega-3 acid known as EPA that’s found in fish oil.

ADA is already one step ahead there. In its guidelines, the organization specified that "data are lacking with other omega-3 fatty acids, and results of the REDUCE-IT trial should not be extrapolated to other products."

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