Amarin Loses Latest Appeal for Vascepa SPA

September 19, 2014

The FDA once again rejected Amarin’s appeal for the agency to reinstate a special protocol assessment (SPA) on a phase III study of its triglyceride drug Vascepa, a move that casts doubt on the drugmaker’s ability to expand its indication on the fish oil-based product.

Vascepa (icosapent ethyl) won FDA approval in 2012 to lower triglyceride levels in adults with severe hypertriglyceridemia. Amarin is seeking a sNDA to also treat patients with mixed dyslipidemia at high risk for heart disease and who are taking statins, a larger patient population.

The agency initially had granted an SPA for Amarin’s ANCHOR trial. An SPA is granted before a trial is completed, and represents agency confidence that the trial’s design, endpoints and analyses will be sufficient to support regulatory approval of the drug. The SPA is intended to iron out any issues with a trial before it is completed.

But the FDA rescinded the SPA last fall for Amarin’s ANCHOR trial amid doubts that a triglyceride-lowering drug can significantly reduce the risk of cardiovascular events. The agency cited three outcomes trials of triglyceride-lowering drugs to support its conclusion: Merck’s HPS2-THRIVE trial of MK-0524A (niacin/laropiprant), Abbott’s ACCORD trial of Trilipix (fenofibric acid) and Abbott’s AIM-HIGH trial of Niaspan (niacin extended-release) in combination with a statin.

Amarin lost its first appeal to reinstate the SPA in January, a move that prompted it to appeal to the agency’s Office of New Drugs, which issued the latest rejection. Amarin could appeal its case to Commissioner Margaret Hamburg, but didn't signal whether it plans to do so.

The company did note that it believes in its regulatory and scientific arguments for reinstatement, but acknowledged that such a development “would be an uphill battle.”

With reinstatement looking less likely, Amarin said in its annual report that the best way to get approval for the indication is to use data from an ongoing large cardiovascular outcomes trial called REDUCE-IT, but that trial isn’t scheduled to be completed until 2017.

The agency has yet to make a decision on the sNDA, the drugmaker said. With the latest denial, there is a “low probability” that the sNDA will get approved, according to a note from the investment research firm Oppenheimer & Co.

Amarin has hinted that if the sNDA is rejected, it may discontinue REDUCE-IT.

Oppenheimer expects a decision on REDUCE-IT in the coming months, and noted that the study is costing Amarin between $30-40 million a year.

This isn’t the only fight Amarin is waging against the FDA. Earlier this year Amarin sued the FDA seeking five years of market exclusivity for Vascepa instead of the three years it was initially rewarded. The lawsuit is still ongoing. — Robert King


Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.