MHRA Grants Approval for Use of Vazkepa in Great Britain

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted an approval for Vazkepa (icosapent ethyl) to be used as a treatment to reduce the risk of cardiovascular events in high-risk statin-treated adult patients in Great Britain.

According to an April 22, 2021 press release from Amarin Corporation, MHRA’s license, which has rapidly followed the European Commission’s marketing authorization decision, is among the first under the new ‘reliance’ route post-BREXIT. Icosapent ethyl has been identified as a new active substance that likely features multi-factorial mechanisms of action, with the mechanisms of action contributing to the reduction of cardiovascular events not completely understood.

The regulatory authority’s decision has been based upon clinical trial results of the REDUCE-IT study, in which 8179 statin-treated adult patients with moderately elevated triglyceride levels were followed for a median duration of 4.9 years. In the study, icosapent ethyl achieved the primary composite endpoint and demonstrated risk reduction in the key secondary composite endpoint. More information can be found in the company’s press release, sourced below.

“The REDUCE-IT study shows icosapent ethyl could reduce CV [cardiovascular] events and has the potential to change the way residual cardiovascular risk is treated,” said Professor Gabriel Steg, co-author of the REDUCE-IT study and chief, Department of Cardiology at Hôpital Bichat, Paris, in the press release. “This authorization of icosapent ethyl can make a difference to patients who are at high-risk of suffering from a heart attack or stroke. Eligible patients can be confident we have a new treatment that is backed by evidence-based data and European guideline recommendations.”

“We began developing icosapent ethyl in Europe more than a decade ago. We are very grateful to the many patients and physicians who contributed to the development and clinical study of icosapent ethyl. Icosapent ethyl can help to reduce strokes, heart attacks, and other major cardiovascular events in high-risk patients across Europe,” added John Thero, president and CEO of Amarin, in the press release. “We are dedicated to a rethinking of cardiovascular disease risk reduction in Europe with an emphasis on preventative care. We will work tirelessly throughout Europe to make icosapent ethyl available to all patients who may benefit from this therapy.”

Source: Amarin