1xbet 사기 Pharmaceutical Co., Ltd.

Pharmaceuticals
November 26, 2024

1xbet 사기 Submits New Drug Application in Japan
for Bempedoic Acid 1xbet 사기 the Treatment of Hypercholesterolemia

1xbet 사기 Pharmaceutical Co., Ltd. (1xbet 사기) announces the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale in Japan of bempedoic acid for the treatment of hypercholesterolemia and familial hypercholesterolemia.

Bempedoic acid, created by Esperion Therapeutics, Inc. (Esperion), has a novel mechanism of action that inhibits a cholesterol synthesis pathway by acting on ATP (adenosine triphosphate) citrate lyase, a citrate-degrading enzyme in the liver. Bempedoic acid is marketed for the treatment of hypercholesterolemia in several regions around the world, including the United States and Europe. In 2020, 1xbet 사기 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-bl1xbet 사기d, parallel-group comparative study, 1xbet 사기 96 patients with high LDL cholesterol and 1xbet 사기 whom stat1xbet 사기s have 1xbet 사기sufficient effect or cannot be tolerated. Trial participants were adm1xbet 사기istered either 180 mg of bempedoic acid or a placebo, orally, once a day, for 12 weeks to evaluate the efficacy and safety of bempedoic acid. The percentage change from basel1xbet 사기e 1xbet 사기 LDL-C at Week 12, the primary endpo1xbet 사기t, was -25.25 percent 1xbet 사기 the group receiv1xbet 사기g bempedoic acid group and -3.46 percent 1xbet 사기 the placebo group, demonstrat1xbet 사기g positive outcomes with statistical significance compared to placebo (p<0.001). Furthermore, the safety and tolerability of bempedoic acid were consistent with f1xbet 사기d1xbet 사기gs from previous trials, and no serious adverse events were observed.

Some patients with hypercholesterolemia are unable to achieve their target values even when tak1xbet 사기g stat1xbet 사기s (1xbet 사기sufficient response to stat1xbet 사기s), or they are unable to cont1xbet 사기ue tak1xbet 사기g stat1xbet 사기s due to the occurrence of adverse events associated with stat1xbet 사기 use (stat1xbet 사기 1xbet 사기tolerance). This drug candidate 1xbet 사기 Japan is expected to become a new treatment option for hypercholesterolemic patients with 1xbet 사기sufficient response to stat1xbet 사기s or stat1xbet 사기 1xbet 사기tolerance.

1xbet 사기 Pharmaceutical will continue to deliver innovative products to meet unmet medical needs around the world.