Ziopharm Oncology (ZIOP) recently announced that the FDA has cleared an investigational new drug app...
Esperion Seeks to Reduce Cardiovascular Events
09/17/2019 5:00 am EST
Esperion Therapeutics (ESPR) just announced the completion of patient enrollment in the CLEAR Cardiovascular Outcomes Trial (CVOT), notes biotech specialist John McCamant, editor of The Medical Technology Stock Letter.
The trial is designed to evaluate whether treatment with bempedoic acid reduces the risk of cardiovascular events in patients with statin intolerance (or “statin averse”) who have cardiovascular disease or are at high risk for cardiovascular disease.
CLEAR Outcomes is an event-driven trial and will conclude once the predetermined number of major adverse cardiac events (MACE) occur. Based on estimated cardiovascular event rates, ESPR expects to meet the target number of events in the H2:22.
This is an important event as positive CVOT data will significantly add value to the drug candidate. The randomized, multi-center, double-blind, placebo-controlled trial is designed to evaluate whether treatment with bempedoic acid reduces the risk of cardiovascular events.
The primary endpoint of the study is the effect of bempedoic acid on major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization; also referred to as “four-component MACE”). The study enrolled 14,032 patients at over 1,200 sites in 32 countries.
Bempedoic acid and the bempedoic acid with ezetimibe combination tablet are poised for FDA approval next year. The FDA has set a PDUFA date for the completion of the bempedoic acid NDA review for February 21, 2020, and the PDUFA date for completion of the bempedoic acid-ezetimibe combination tablet NDA review for February 26, 2020.
In our view, bempedoic acid and the ezetimibe combo pill have been significantly de-risked having delivered a slew of positive Phase III data and both have a very good chance of receiving FDA approval.
While the CVOT trial will not be concluded until 2022, ESPR should be able to deliver solid sales until that time as there remains a significant need for a new anti-cholesterol pill that works in statin failure patients.
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