UK MHRA approves Vazkepa to reduce the risk of cardiovascular events – Amarin Corp

Amarin Corporation announced that the Medicines and Healthcare products Regulatory Agency (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 (at least 150 mg/dL) and either established cardiovascular disease or diabetes, and at least one additional cardiovascular risk factor.

Marketing authorisation of icosapent ethyl comes after a landmark international, double-blind randomised, placebo-controlled, event-driven REDUCE-IT study in 8,179 statin-treated adult patients with moderately elevated triglyceride levels, were followed for a median duration of 4.9 years. Icosapent ethyl achieved the primary composite endpoint (time to first occurrence of cardiovascular death, heart attack, stroke, coronary revascularisation or hospitalisation for unstable angina)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. It also demonstrated a 26% relative risk reduction and a 3.6% absolute risk reduction in the key secondary composite endpoint (time to first occurrence of cardiovascular death, heart attack or stroke). The most frequently reported adverse reactions associated with icosapent ethyl were bleeding (11.8%), peripheral oedema (7.8%), atrial fibrillation (5.8%), constipation (5.4%), musculoskeletal pain (4.3%), gout (4.3%) and rash (3.0%).

The MHRA’s license follows the European Commission marketing authorisation for icosapent ethyl on 30 March 2021. Icosapent ethyl is amongst the first products to be submitted and licensed through the MHRA’s new ‘reliance’ route following the end of the BREXIT transition period. It has been identified as a new active substance with likely multi-factorial mechanisms of action yet the mechanisms of action contributing to reduction of cardiovascular events with icosapent ethyl are not completely understood.