Bempedoic acid and the bempedoic acid ezetimibe combination tablet are designed to decreased lipid levels in patients with elevated low-density lipoprotein cholesterol. The next step is filing and regulatory review.
The stock jumped more than 12% to $48.47.
“It is exceptional that our New Drug Applications for both bempedoic acid and bempedoic acid ezetimibe combination tablet have been accepted for filing,” President and CEO Tim Mayleben said. “The acceptances validate the extraordinary effort and high-quality submissions of our lipid management team and brings our once-daily, oral bempedoic acid-based therapies one step closer to the physicians and patients who will benefit from them.”
The FDA’s goal dates for completing the regulatory review are in February 2020. There is no plan to hold an advisory committee meeting currently in place.
Esperion, also known as the the lipid management company, is focused on developing once-daily oral therapies for patients with high LDL-Cholesterol.
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