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 vs. pravastatin; a Phase 3 study (n=351) to compare pitavastatin vs. simvastatin in patients with at least two 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 1.026mg, 2.053mg, or 4.106mg of pitavastatin magnesium, which is equivalent to 1mg, 2mg, or 4mg, respectively of free base. Doses of Zypitamag >4mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies; dosing of Zypitamag should not exceed 4mg once daily.
Zypitamag will be available in 30-, 90-, 100-, 500-, and 1000-count bottles.
For more information call (877) 993-8879 or visit ZydusUSA.com.