FDA approves Liptruzet (Merck Inc) for Dyslipidaemia

The FDA has approved Liptruzet (ezetimibe and atorvastatin) tablets, from Merck Inc, for the treatment of Dyslipidaemia. It is indicated for elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Approval is based on results including a multicenter, clinical study in which 628 patients with hyperlipidemia were treated for up to 12 weeks with Liptruzet. It provided LDL cholesterol reductions of 53 percent at the lowest dose (10/10 mg), 54 percent at the 10/20 mg dose, 56 percent at the 10/40 mg dose and 61 percent at the maximum dose (10/80mg).

In two separate clinical studies, Liptruzet provided significantly greater LDL cholesterol reductions and helped more patients get to target LDL cholesterol levels compared to doubling the dose of atorvastatin. The most commonly reported side effects included increased alanine transaminase (5 percent), increased aspartate transaminase (4 percent), and musculoskeletal pain (4 percent).