Icosapent ethyl recommended for EU approval by CHMP to reduce CV risk
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on icosapent ethyl for the reduction of risk of CV events in patients at high CV risk, thereby recommending marketing authorization of icosapent ethyl in the European Union.
The CHMP opinion is based upon data from the REDUCE-IT CV outcomes study, which enrolled more than 8,000 high risk patients who remained at significant risk of heart attack, stroke or other major adverse cardiovascular events (MACE) including death, while LCL-c was well controlled by maximally tolerated statin therapy. In these patients, 4 grams of icosapent ethyl treatment per day reduced the risk in the first occurrence of MACE by 25% compared to placebo.
The CHMP recommends granting marketing authorization of icosapent ethyl to reduce the risk of CV events in adult statin-treated patients at high CV risk with elevated triglyceride levels (≥150 mg/dL), and with established CVD or with diabetes and at least one additional CV risk factor.
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