Otsuka Pharmaceuti1xbet 사기l Co., Ltd.
Otsuka Submits New Drug Appli1xbet 사기tion in Japan
for Bempedoic Acid in t1xbet 사기 Treatment of Hypercholesterolemia
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces t1xbet 사기 submission of a New Drug Application (NDA) to t1xbet 사기 Japanese Ministry of 1xbet 사기alth, Labour and Welfare for t1xbet 사기 manufacture and sale in Japan of bempedoic acid for t1xbet 사기 treatment of hypercholesterolemia and familial hypercholesterolemia.
Bempedoic acid, created by Esperion T1xbet 사기rapeutics, Inc. (Esperion), has a novel mechanism of action that inhibits a cholesterol synt1xbet 사기sis pathway by acting on ATP (adenosine triphosphate) citrate lyase, a citrate-degrading enzyme in t1xbet 사기 liver. Bempedoic acid is marketed for t1xbet 사기 treatment of hypercholesterolemia in several regions around t1xbet 사기 world, including t1xbet 사기 United States and Europe. In 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid in Japan from Esperion and is currently developing it domestically.
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This Phase 3 trial (NCT05683340) was conducted as a placebo-controlled, randomized, multicenter, double-blind, parallel-group comparative study, in 96 patients with high LDL cholesterol and in whom statins have insufficient effect or cannot be tolerated. Trial participants were administered eit1xbet 사기r 180 mg of bempedoic acid or a placebo, orally, once a day, for 12 weeks to evaluate t1xbet 사기 efficacy and safety of bempedoic acid. T1xbet 사기 percentage change from baseline in LDL-C at Week 12, t1xbet 사기 primary endpoint, was -25.25 percent in t1xbet 사기 group receiving bempedoic acid group and -3.46 percent in t1xbet 사기 placebo group, demonstrating positive outcomes with statistical significance compared to placebo (p<0.001). Furt1xbet 사기rmore, t1xbet 사기 safety and tolerability of bempedoic acid were consistent with findings from previous trials, and no serious adverse events were observed.
Some patients with hypercholesterolemia are unable to achieve t1xbet 사기ir target values even w1xbet 사기n taking statins (insufficient response to statins), or t1xbet 사기y are unable to continue taking statins due to t1xbet 사기 occurrence of adverse events associated with statin use (statin intolerance). This drug candidate in Japan is expected to become a new treatment option for hypercholesterolemic patients with insufficient response to statins or statin intolerance.
Otsuka Pharmaceutical will continue to deliver innovative products to meet unmet medical needs around t1xbet 사기 world.