The findings of combined data from four of the company’s Phase 3 studies were presented at the virtual American Heart Association Science Sessions 2020 on Friday. Esperion (NASDAQ: ESPR) told the Associated Press.
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Both trials found a substantial decrease of low-density cholesterol levels by NEXLETOL (bempedoic acid) Tablets by week 12 in set subgroups, including individuals who are unable to handle statins and females, in comparison to placebo.
The women are half the population, and about 10 million people with elevated LDL-C levels are not on statins in the U.S. because of tolerability problems, said Ashley Hall, Chief Development Officer for Esperion. The observations indicate significant effectiveness of LDL-C and sufficient protection for NEXLETOL within these subgroups.
Authorized by the US earlier this year. NEXLETOL, introduced at the height of the COVID-19 pandemic by the FDA, is the first oral, once-daily, non-statin LDL-C-lowering treatment available in nearly 20 years for indicated patients.
In these trials, when used with mild or high-intensity statins, NEXLETOL produced an average 18 percent placebo-corrected lowering of LDL-C. Upper respiratory tract inflammation, muscle spasms, hyperuricemia, back pain, stomach pain or nausea, bronchitis, extremity pain, anemia, and elevated liver enzymes were the most frequent adverse side effects.
For the cure of adults with HeFH or existing ASCVD that need a further reduction of LDL-C, NEXLETOL is suggested as an alternative to dietary and sufficiently tolerated statin therapy. The efficacy of NEXLETOL has not yet been established on cardiovascular morbidity and mortality.
On the close of November 13, 2020 Company, shares pared rose sharply to 3.09% at 28.69. The
Biotech giant with a Market capitalization of 775.78M has a year-to-date performance of -51.89% in contrast with the weekly performance of 13.62%.
