London, UK - 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
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.