Apr 22, 2021: “Amarin Corporation announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Marketing Authorization for VAZKEPA (icosapent ethyl) as a treatment to reduce the risk of cardiovascular events in high cardiovascular risk statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes, and at least one additional cardiovascular risk factor.
The Great Britain Marketing Authorization for VAZKEPA applies to England, Scotland and Wales. Under the Brexit Northern Ireland agreement, the European centralized marketing authorization for the European Union covers Northern Ireland.
The MHRA’s license swiftly followed the European Commission (EC) marketing authorization of icosapent ethyl for the European Union as announced on March 30, 2021.
Amarin’s understanding is 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.
Icosapent ethyl has been identified as a new active substance with likely multi-factorial mechanisms of action.
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.”
The publication of this research has led to icosapent ethyl being recommended for use in high-risk statin-treated patients identified by moderately elevated triglycerides by 15 global medical societies around the world including the European Society of Cardiology and the European Atherosclerosis Society.
Cardiovascular risk (CVD) is one of the leading causes of death in the United Kingdom, with heart and circulatory diseases causing more than a quarter (27%) of all deaths in the UK, which is more than 160,000 deaths each year.
The marketing authorization is also timely in the wake of the COVID-19 pandemic, which has resulted in the reprioritization of clinical resources, often leaving patients with serious cardiovascular disease to delay much needed medical help.
Preventative care is needed for at-risk patients with cardiovascular disease, including LDL-cholesterol management and additional treatments for statin-treated patients with residual cardiovascular risk, identified by elevated triglycerides and other risk factors, to address their unmet need.
“Icosapent ethyl has been helping to reduce strokes, heart attacks and other major cardiovascular events in high-risk patients in the United States,” stated John Thero, president and chief executive officer of Amarin.
“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.”
In addition, the company announced that subsequent to the marketing authorization by the EC, the Norwegian Medicines Agency informed Amarin of its marketing authorization for VAZKEPA in Norway.”