MHRA gives green light to new cardiovascular treatment
pharmafile | April 23, 2021 | News story | Medical Communications | MHRA, cardiovascular
The MHRA has granted a Great Britain Marketing Authorisation 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 and either established cardiovascular disease or diabetes, and at least one additional cardiovascular risk factor.
The drug was developed by Amarin Corporation and the company said it was amongst 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. However, the mechanisms of action contributing to reduction of cardiovascular events with icosapent ethyl are not completely understood.
Marketing authorisation was granted based on data from the international REDUCE-IT study in 8,179 statin-treated adult patients, which was a culmination of a decade’s worth of evidence-based cardiovascular clinical outcomes research.
Icosapent ethyl achieved the primary composite endpoint with a 25% relative risk reduction and a 4.8% absolute risk reduction in the first occurrence of major adverse cardiovascular events in comparison to placebo. The drug also demonstrated a 26% relative risk reduction and a 3.6% absolute risk reduction in the key secondary composite endpoint.
Professor Gabriel Steg, co-author of the REDUCE-IT study and Chief at the Department of Cardiology at Hôpital Bichat, Paris, said: “The REDUCE-IT study shows icosapent ethyl could reduce cardiovascular events and has the potential to change the way residual cardiovascular risk is treated.
“This authorisation 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.”
Strokes and heart attacks triggered by cardiovascular disease are the most common cause of death in Europe. The economic burden of cardiovascular disease in the EU exceeds €210 billion a year and is expected to increase over the coming decades.
Amarin’s President and Chief Executive Officer, John Thero, said: “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. 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.”
Kat Jenkins
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