Amarin Corporation Plc (NASDAQ:AMRN) received MA (Marketing Authorization) for its innovative drug formulation – from the European Commission.
Receives approval for VASCEPA from US FDA
The new drug (VAZKEPA) will be used to treat patients with high cardiovascular risk. In December 2019, Amarin already obtained the approval of the US FDA for VAZKEPA to reduce cardiovascular risk. The company markets this drug under the brand name – VASCEPA in the US.
President (R&D) and CSO of Amarin, Steven Ketchum, said the nod of EC for its drug – Icosapent Ethyl is a significant achievement for the company to cure patients suffering from high cardiovascular risk in Europe. Steven said the company will plan to introduce Icosapent Ethyl in Europe and make a difference in the lives of several million people.
After several years of development/ testing of Icosapent Ethyl, EC approved the drug, such as safety and efficacy data obtained from REDUCE-IT cardiovascular outcomes.
In the REDUCE-IT, the company evaluated over 8,000 high-risk patients at higher risk of stroke, cardiovascular risk of heart attack, or adverse cardiovascular events.
CEO of Amarin, John F. Thero, said the company is thrilled to receive the approval of the EC for Icosapent Ethyl to mitigate the risk of cardiovascular risk of a heart attack.
Cardiovascular disease is the chief cause of death in the EU. The annual spending to tackle this disease in the EU is more than Euro 210 billion.
Icosapent Ethyl receives the support of 15 medical societies
Amarin is pleased to report that 15 medical societies have endorsed the use of Icosapent Ethyl to treat patients with a high risk of cardiovascular disease.
Medical societies such as EHJ (Egyptian Heart Journal) and CCS (Canadian Cardiovascular Society) have added VAZKEPA in their Egyptian Heart Journal’s Practical Guidance and Canadian Cardiovascular Society Guidelines 2021 mitigate cardiovascular risk.
Icosapent Ethyl is now rapidly becoming standard care of unit to treat high-risk cardiovascular disease patients.
MHRA (Medicines and Healthcare Products Regulatory Agency) of the UK approved Icosapent Ethyl to treat patients who are suffering at high risk of cardiovascular disease in the UK. The data obtained from the REDUCE-IT clinical study shows that demonstrated a reduction of 25% in the first incidence of a significant cardiovascular event.