Cholib fenofibrate/simvastatin regulatory update

EMA's CHMP issued a positive opinion recommending approval of 145/40 and 145/20 mg Cholib fenofibrate/simvastatin to reduce triglycerides and increase HDL-C. Specifically, the fixed-dose combination is indicated as an adjunctive therapy to diet and exercise in high cardiovascular risk adults with mixed dyslipidemia when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy. ...