EMA Panel Gives Thumbs-up to Fenofibrate/Simvastatin (Cholib) Combo


June 28, 2013

LONDON, United Kingdom — The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending that a combination tablet of fenofibrate/simvastatin (Cholib, Abbott Healthcare, Abbott Park, IL) be approved as an adjunct to diet and exercise in high-risk patients with mixed dyslipidemia [1].

The drug received a "positive opinion" from CHMP for two doses of the fenofibrate/simvastatin combination: 145 mg/40 mg and 145 mg/20 mg, respectively. The drug is approved for reducing triglycerides and increasing HDL-cholesterol levels in high-CV-risk patients when LDL-cholesterol levels are inadequately controlled with simvastatin 20 mg or 40 mg.

The most common adverse events reported with Cholib include upper-respiratory-tract infection, gastroenteritis, increased platelet counts, and increased alanine aminotransferase and blood creatinine. According to the committee, "on the basis of quality, safety, and efficacy data submitted, [CHMP] considers there to be a favorable benefit-to-risk balance for Cholib and therefore recommends the granting of the marketing authorization."

A positive opinion from CHMP is a prerequisite to European Union approval of a product by the European Commission, which has 67 days from the date of the opinion to grant approval.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.