Seeking Alpha

U.S. FDA Updates LDL-C Lowering Indication for Esperion’s NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet

– Cardiovascular (CV) Risk Reduction Labels Remain on Track: in U.S. with PDUFA Date of March 31; in Europe with Anticipated Approval in 1H 2024 – ANN ARBOR, Mich., Dec. 13, 2023 (GLOBE NEWSWIRE) -- ...
MedPage Today

Expanded Label Officially Makes Bempedoic Acid a CVD Prevention Medication

The FDA approved label expansions for bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) so they can be used more broadly as cardiovascular prevention drugs, Esperion announced Friday.
Healio

Bempedoic Acid Topic Review

Bempedoic acid (Nexletol, Esperion Therapeutics) is a nonstatin low-density lipoprotein cholesterol (LDL-C)-lowering drug. It is a first-in-class, small molecule inhibitor of adenosine ...
TCTMD

Bempedoic Acid Gains CV Risk Reduction Indication

The US Food and Drug Administration has approved expanded labeling for both bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) to include a new indication for cardiovascular risk ...
Business Insider

Esperion Announces Two Data Presentations of NEXLETOL® (bempedoic acid) Tablet at the ESC Congress 2020

ANN ARBOR, Mich., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that it will present a pooled analysis from four Phase 3 clinical trials of NEXLETOL ® (bempedoic acid) ...
Business Wire

Esperion and Daiichi Sankyo Europe Announce $125 Million Amendment to Their Collaboration, Including Resolution of Pending Litigation

– Near term payment to Esperion of $100 million plus $25 million in calendar quarter following EMA’s expected decision on Type II(a) variation approval of NILEMDO ® (bempedoic acid) Tablet and ...
TCTMD

Bempedoic Acid Reassures in Patients With and Without Diabetes: CLEAR Outcomes

The use of bempedoic acid (Nexletol; Esperion) safely lowers LDL cholesterol levels and reduces cardiovascular events in statin-intolerant patients with and without diabetes, according to results of a ...
Medscape

FDA Expands Indications for Bempedoic Acid in CVD Prevention

The US Food and Drug Administration (FDA) has expanded the indications for bempedoic acid (Nexletol) and bempedoic acid plus ezetimibe combination (Nexlizet) to prevent heart attacks and ...
Nasdaq

Esperion Announces New Drug Submissions in Canada for NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Treatments to Reduce LDL-C and Cardiovascular Risk

ANN ARBOR, Mich., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has filed New Drug Submissions (NDSs) to Health Canada for NEXLETOL and NEXLIZET, once-daily, ...
CNN

Esperion Announces Commercial Availability of the NEXLETOL™ (bempedoic acid) Tablet and Pledges a Conscientious Launch During Unprecedented Moment in Healthcare

– First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine in the U.S. in Nearly 20 Years for Indicated Patients Awaiting a New Option – – Esperion Aims to Set New Industry Standard by ...
Seeking Alpha

Otsuka Submits New Drug Application in Japan for Bempedoic Acid in the Treatment of Hypercholesterolemia

ANN ARBOR, Mich., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka) has submitted a New Drug Application (NDA) to the Japanese ...