FDA Approves Pitavastatin as Adjunctive Therapy for Hyperlipidemia or Mixed Dyslipidemia

The Food and Drug Administration (FDA) has approved Zypitamag (pitavastatin; Zydus), an HMG Co-A reductase inhibitor, for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C).

The efficacy of pitavastatin was evaluated in various clinical studies: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study (n=251) to evaluate the efficacy of pitavastatin vs placebo; a Phase 3 non-inferiority study (n=817) to compare pitavastatin vs atorvastatin; a Phase 3 non-inferiority study (n=843) to compare pitavastatin vs simvastatin; a Phase 3 non-inferiority study (n=942) to compare pitavastatin vspravastatin; a Phase 3 study (n=351) to compare pitavastatin vs simvastatin in patients with at least 2 risk factors for coronary heart disease; and a Phase 3 study (n=410) to compare pitavastatin vs atorvastatinin patients with type 2 diabetes mellitus and combined dyslipidemia. 

Each film-coated tablet of Zypitamag contains 1.026 mg, 2.053 mg, or 4.106 mg of pitavastatin magnesium, which is equivalent to 1 mg, 2 mg, or 4 mg, respectively of free base. Doses of Zypitamag >4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies; dosing of Zypitamag should not exceed 4 mg once daily.

Zypitamag will be available in 30-, 90-, 100-, 500-, and 1000-count bottles.

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For more information call (877) 993-8879 or visit ZydusUSA.com.

This article originally appeared on MPR