Amarin takes application to expand Vascepa label to the FDA as M&A chatter heats up

Having unveiled an unexpected set of heart protective results for their fish oil-derived pill Vascepa, Amarin is marching ahead to fulfill blockbuster expectations for its cholesterol-lowering drug by submitting an application to expand Vascepa’s label to include the reduction in cardiovascular risk.

The company sparked a flurry of M&A chatter after revealing data from the REDUCE-IT study last year — a 25% reduction in the risk for the first occurrence of a major cardio event, and a 26% reduction for 3-point MACE, a composite of cardiovascular death, nonfatal heart attack and nonfatal stroke — although concerns about the impact of the mineral oil placebo on the results prompted lingering questions. Earlier this month, Amarin debuted its exploratory analysis of the trial, with researchers suggesting a 30% reduction in cardiovascular events compared to the placebo arm.

John Thero

“The REDUCE-IT results support that approximately 1 fewer major cardiovascular adverse event would occur on average for every 6 patients treated with Vascepa for 5 years on top of statin therapy compared to placebo,” Amarin chief John Thero said in a statement.

On Thursday, Amarin said it was operating under the assumption that the sNDA will be reviewed over a standard ten months resulting in a PDUFA date near the end of January 2020, and that it expects the regulator with organize an advisory committee meeting of outside experts to deliberate and recommend whether Vascepa’s label should be expanded before the FDA makes its final decision.

Earlier in the week, the American Diabetes Association issued fresh “standards of care” guidelines to include Vascepa. They recommended  that Vascepa “be considered for patients with diabetes and atherosclerotic cardiovascular disease or other cardiac risk factors on a statin with controlled LDL-C, but with elevated triglycerides to reduce cardiovascular risk.”

Vascepa, which generated about $229 million in 2018 sales, comprises omega-3 acid called EPA derived from fish — was originally approved in 2012 for patients with severe hypertriglyceridemia. It is reasonably priced with an annual price tag of roughly $2400, Amarin contends, adding that the majority of insured patients insurance who obtain Vascepa prescriptions pay a monthly co-pay charge of $9.99 or less.

If and when Vascepa’s label is expanded, the company aims to keep Vascepa “affordably priced” Thero told Endpoints News in an emailed statement.

Meanwhile, PCSK9 inhibitors that were approved in 2015 carried a price close to $14,000 and were pegged to attain blockbuster status for their ability to dramatically lower levels of LDL cholesterol, facing pushback from insurers for their high sticker prices that led to lower adoption than expected, despite later trials that demonstrated they also significantly cut the risk of heart attacks and stroke. Following Amgen’s decision to slash the price of its PCSK9 drug Repatha by 60% to $5,850 last year, the team behind their main rival treatment, Praluent — Regeneron $REGN and Sanofi $SNY — have followed suit with the same discount, beginning early March.

In 2016, Amarin $AMRN won a landmark ruling against the FDA, which allowed the drugmaker to exercise its first amendment rights by promoting Vascepa for off-label uses as long as it does so ‘truthfully.’ The company was also seeking to market the drug to patients with not just severe triglyceride levels, but those considered to have ‘high’ levels of the blood fat.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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