Quarterly Sales (Approved)
August 10, 2020
Amp Volatility Score
Catalyst Info & Data Links
TITLE: Bempedoic Acid/ Ezetimibe (Nexlizet) (FDA-approved Drug) - Quarterly Sales
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
07-01-2020 Publication in the Journal of the American Medical Association Cardiology of Pooled Efficacy Analysis from the Phase 3 LDL-C Lowering Clinical Development Program of NEXLETOL® (bempedoic acid) Tablets
02-26-2020 PDUFA Approval PR FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine
08-27-2018 Positive Top-Line Results from Pivotal Phase 3 Bempedoic Acid / Ezetimibe Combination Pill Study
2018: Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: a randomized, placebo-controlled study. Atherosclerosis, 277, 195-203.
2019: Efficacy and safety of bempedoic acid in patients with hypercholesterolemia and statin intolerance. Journal of the American Heart Association, 8(7), e011662.
~One in 250 adults (an estimated 834,000 people) have the Familial hypercholesterolemia genetic mutation (learn more).
MECHANISM OF ACTION / RATIONALE
NEXLIZET contains bempedoic acid and ezetimibe. NEXLIZET reduces elevated LDL-C through inhibition of cholesterol synthesis in the liver and absorption in the intestine.
Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Bempedoic acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively. ACSVL1 is expressed primarily in the liver. Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of low-density lipoprotein receptors.
Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the blood.
Source - FDA Label (section 12.1)
Updated by HC
ESPR, Hypercholesterolemia, Bempedoic Acid, Ezetimibe, Nexlizet,
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
See What The Community Is Saying - Click To See Full Post