The US Food and Drug Administration (FDA) has approved Merck’s Juvisync, a once-daily therapy for type 2 diabetes that combines glucose-lowering medication sitagliptin, the active component of Januvia, with cholesterol-lowering medication simvastatin.
The approval is based upon clinical bioequivalence studies in healthy subjects, which demonstrated that the administration of Juvisync is equivalent to the co-administration of corresponding doses of the two individual medications as separate tablets.
Juvisync will enable healthcare providers to help patients who need the blood sugar-lowering benefits of a dipeptidyl peptidase-4 inhibitor and the cholesterol-lowering benefits of simvastatin with the convenience of a single tablet once daily.
However, the therapy should be discontinued immediately if markedly elevated creatine phosphokinase levels occur or myopathy is diagnosed or suspected, the company said.
