EMA grants marketing authorisation for Amarin’s heart attack treatment

pharmafile | February 1, 2021 | News story | Sales and Marketing |  Amarin, EMA 

Amarin have been granted authorisation from the EMA to market a treatment that will reduce the chance of heart attacks and strokes for those most at risk.

The treatment, currently known as icosapent ethyl, will use the brand name VAZKEPA if it is approved by the European Commission, the next stage in the reviewal process. A decision is expected by April.

The opinion from the EMA follows the REDUCE-IT study, which took place over more than 10 years and evaluated over 8,000 patients.

In the study, all patients remained treated by statins and other contemporary therapies, with half also given a placebo and half given icosapent ethyl. Those treated with icosapent ethyl reported a 25% relative risk reduction in the first occurrence of major adverse cardiovascular events over a period of almost five years.

The treatment will be used mostly on adult statin-treated patients at high cardiovascular risk with elevated triglycerides, as well as established cardiovascular disease or diabetes and another risk factor.

Steven Ketchum, Senior Vice President and Chief Scientific Officer of Dublin-headquartered Amarin said: “This positive CHMP (Committee for Medicinal Products for Human Use) opinion is a significant milestone for Amarin, taking us one step closer to making this important therapy available to millions of patients in the European Union at high risk of cardiovascular events such as heart attacks and strokes.

“We are dedicated to supporting a rethinking of cardiovascular disease risk reduction in Europe with further emphasis on preventative care.”

Jack Goddard