Amarin Plans to Seek FDA Approval for CV Indication for Fish Oil Drug

Fish Oil pills in the shape of a fish, with pills coming out of its mouth like bubbles

Clinical data for a fish-oil-based drug from Amarin Corporation PLC confirmed the drug’s ability to reduce the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death.

On Sunday, Ireland-based Amarin presented the results from its REDUCE-IT trial at the 2018 Scientific Sessions of the American Heart Association (AHA) in Chicago that showed Vascepa (icosapent ethyl) is effective in benefitting cardiovascular patients. Amarin said the fish oil-based drug had “multiple robust demonstrations of efficacy.” The presentation in Chicago expanded information the company previously released in September about the cardiovascular efficacy of Vascepa.

In its data, Amarin said the cardiovascular benefits of Vascepa do not appear to be significantly influenced by triglyceride levels at baseline, or as achieved at one year. That suggests that there are mechanisms at work in Vascepa that are independent of triglyceride reduction, the company said. Vascepa has already been approved to treat patients with triglyceride levels higher than 500 milligrams per deciliter, triple normal levels. Amarin said trial results were robust across multiple subgroups, including in patients with and without diabetes at baseline.

Trial data showed that patients receiving Vascepa in addition to statin therapy saw a risk reduction of 31 percent to experiencing a heart attack, a 28 percent risk reduction for stroke, and a 20 percent risk reduction in CV-related death.  

The REDUCE-IT study includes 8,179 statin-treated adults with an elevated risk of cardiovascular concerns. Approximately 59 percent of the patients had diabetes at baseline and approximately 71 percent of the patients had established cardiovascular disease at the time of enrollment. Amarin noted that there is no therapy currently approved to treat the residual risk in REDUCE-IT patients, but also pointed out that no other therapy has demonstrated a 25 percent risk reduction on top of statin therapy in a major cardiovascular outcomes trial.

Trial data shows a 25 percent risk reduction in the first occurrence of major adverse cardiovascular events (MACE) in the intent-to-treat population, which consisted of a composite of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), nonfatal stroke, coronary revascularization (procedures such as stents and by-pass) and unstable angina requiring hospitalization. 

Based on the results of the REDUCE-IT trial, Amarin said it intends to submit a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) in early 2019 in order to expand the Vascepa’s approval indication.

Steven Ketchum, Amarin’s head of research and development, as well as its chief scientific officer, said the robustness and consistency of the clinical results are exciting.

"Extensive scientific evaluation led to the design and conduct of this study, but the degree of benefit shown with Vascepa nevertheless exceeded our expectation. We believe that these positive results identify an important new treatment option to help lower cardiovascular risk in appropriate patients,” Ketchum said in a statement. “Cholesterol management lowers cardiovascular risk by 25-35 percent. REDUCE-IT suggests that the residual 65-75 percent cardiovascular risk beyond cholesterol management can be significantly lowered with Vascepa in studied patients."

John F. Thero, president and chief executive officer of Amarin, noted that the company has spent more than $500 million on the development of Vascepa. The company’s priorities have shifted to educating the world regarding the results of the REDUCE-IT trial so that “the pain, loss of productivity and high costs of cardiovascular events can be reduced.”

With the potential regulatory approval, Amarin is in the process of increasing its sales team in the United States.

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