Health Canada approves Vascepa to reduce the risk of CV events.- HLS Therapeutics.
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Amarin Corporation announced the presentation of REDUCE-IT HEART FAILURE (HF) data. The REDUCE-IT HF analyses examined the effects of Vascepa (icosapent ethyl) on the incidence of new heart failure by achieved on-treatment serum EPA levels in REDUCE-IT patients.
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.
MHRA Explanatory Note: For a period of two years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralised procedure.Great Britain refers to England, Scotland and Wales.This route – the EC Decision Reliance Procedure (ECDRP) - is available to MAs approved via the centralised procedure.