Amarin’s Vazkepa Launched in Germany

September 13, 2021—Amarin Corporation plc announced the first European market launch of Vazkepa (icosapent ethyl) with its introduction in Germany.

According to the company, Vazkepa (Vascepa in the United States) is indicated in Europe as a treatment to reduce the risk of cardiovascular (CV) events in statin-treated adult patients at high CV risk who have elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and either established CV disease or diabetes and at least one additional CV risk factor.

The launch of Vazkepa in Germany featured a scientific conference in Berlin titled, “New Therapeutic Strategies for Residual CV Risk Management,” which highlighted the scientific underpinnings and clinical benefits of Vazkepa/Vascepa in reducing CV risk. The symposium was led by eleven internationally renowned CV specialists, was attended by > 200 health care professionals from Germany, and was live-streamed to many more physicians across the continent. The event has been archived and is available to physicians across Europe.

Amarin advised that the company has filed market access dossiers in five out of the 10 planned “first wave” European country submissions: Germany, the United Kingdom, France, Italy, and Denmark. During the next quarter, Amarin plans to submit the remaining five dossiers.

The European launch, beginning with Germany, is supported by more than a decade of evidence from CV clinical outcomes, including the landmark REDUCE-IT study, which established that Vazkepa/Vascepa lowers the risk of a life-threatening heart attack or stroke by 25% when added to a statin in the targeted population.

Amarin noted that Vazkepa has been included in the treatment guidelines for CV disease prevention by the European Society of Cardiology, the European Association of Preventive Cardiology, and the European Atherosclerosis Society, in addition to 17 other medical guidelines around the world.

In March 2021, the company announced that Vazkepa received marketing authorization from the European Commission. Approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom was received in April 2021.

With its global headquarters in Ireland and a new commercial hub in Zug, Switzerland, Amarin has strong European roots and the infrastructure necessary to support the company’s plans to build a local commercial presence in all major European markets for a series of successful launches across the continent.

Known as Vascepa in the United States, Amarin launched the product in January 2020 after FDA approval for the treatment of high-risk patients with persistent CV risk after statin therapy. Vascepa was initially launched in the United States in 2013 based on the drug’s initial FDA-approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. In addition to the United States, Vascepa is approved and commercially available in Canada, Lebanon, and the United Arab Emirates.