The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Marketing Authorization for Amarin’s Vazkepa (icosapent ethyl) as a treatment to reduce the risk of cardiovascular events in adult patients.
The Great Britain Marketing Authorisation for Vazkepa covers the use of the drug to reduce the risk of CV events in high CV risk statin-treated adult patients who have elevated triglycerides and either established CV disease or diabetes and at least one additional CV risk factor.
The MHRA’s license swiftly followed the European Commission (EC) marketing authorization of icosapent ethyl for the European Union (EU) last month and, according to a statement from Amarin, it is their understanding that icosapent ethyl is among the first products to be submitted and licensed through the MHRA’s new ‘reliance’ route following the end of the Brexit transition period.
The MHRA authorization for Vazkepa is based on over a decade of development and testing of icosapent ethyl, including efficacy and safety data from the REDUCE-IT® cardiovascular outcomes study. REDUCE-IT evaluated more than 8,000 high-risk patients who despite having their cholesterol levels well controlled by statin therapy remained at significant risk of heart attack, stroke, or other major adverse cardiovascular events (MACE), including death. As published, patients in the REDUCE-IT study had a median follow-up period of nearly five years. Results from this study, in which all patients remained treated with statins (and with other contemporary therapies) and where half the patients received icosapent ethyl and the other half received placebo, demonstrated a 25% relative risk reduction (p<0.001) in the first occurrence of MACE in the intent-to-treat patient population with use of icosapent ethyl (4 grams daily) compared with placebo.
Professor Gabriel Steg, M.D., Chief, Department of Cardiology at Hôpital Bichat, Paris, commented: “The REDUCE-IT study shows icosapent ethyl could reduce CV events and has the potential to change the way residual cardiovascular risk is treated. 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.”
John Thero, president and chief executive officer of Amarin said: “Icosapent ethyl has been helping to reduce strokes, heart attacks and other major cardiovascular events in high-risk patients in the United States. We are dedicated to the rethinking of cardiovascular disease risk reduction across Europe with an emphasis on preventative care. Amarin will work tirelessly throughout Europe to make icosapent ethyl available to all patients who may benefit from this important therapy.”
1 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.