Esperion Therapeutics Inc (NASDAQ:ESPR) has announced that the U.S. Food and Drug Administration has given it confirmation that the low-density lipoprotein cholesterol (LDL-C) program is enough to support the approval of bempedoic acid.
The firm which is based in the Ann Arbor area of Michigan is planning on filing an NDA – New Drug Application with the Food and Drug Administration in early 2019. This is on condition that the phase 3 trial which is currently ongoing turns out to be successful. The pharmaceutical firm is also planning on filing a European Medicines Agency’s Marketing Authorization Application by the end of 2019’s first quarter.
Four studies
In the third phase trial program, four distinct studies are being conducted with each study focusing on different symptoms that have been observed in patients. The differences in symptoms mostly have to do with the level of cholesterol in a patient. In one group, the patients are suffering from hypercholesterolemia where the cholesterol levels in their blood system is high.
Another group consists of patients who are capable of tolerating a dose of Statin that is lower than the recommended daily dosage. Statins are drugs used in lowering the level of cholesterol in the blood. The third group consists of those patients who are statin-intolerant and the fourth one comprises of those who have been put on low-dosage statin in combination with ezetimibe.
Study results
The tolerability study results as well as the safety study results are expected to be out before the end of 2018’s second quarter. Efficacy results, on the other hand, are expected to have been released by mid next year.
With bempedoic acide, Esperion intends it to be utilized in combination with statin in patients who are suffering from hypercholesterolemia.
“We continue to believe that bempedoic acid has the potential to provide physicians with a complementary and convenient oral treatment option that’s cost-effective for their patients with hypercholesterolemia who require additional LDL-C lowering,” Esperion’s chief executive officer, Tim Mayleben, said.
In Monday’s trading session, shares of Esperion Therapeutics Inc jumped by 74.17% to close the day at $41.22 a share.