Enforcement Report - Week of April 24, 2024
CHMP positive opinions for bempedoic acid and the bempedoic acid / ezetimibe
FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET®
Enforcement Report - Week of September 13, 2023
MUNICH--(BUSINESS WIRE)--Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced results from two prespecified analyses from the Phase 3 CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes trial. The results, presented at the European Society of Cardiology (ESC) Congress 2023, further support the long-term use of bempedoic acid in patients at high-risk of cardiovascular (CV) events and demonstrate particular benefit in those with diabetes.
MUNICH--(BUSINESS WIRE)--Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced the presentation of results from the Phase 3 cardiovascular CLEAR (Cholesterol Lowering via Bempedoic acid, an ATP citrate lyase (ACL)-Inhibiting Regimen) Outcomes Trial and the multinational observational SANTORINI (Lipid management in patients with high- and very-high CV risk; data from clinical practice in Europe) study. Both studies were presented in a late-breaker session at the 91st European Atherosclerosis Society congress.
After Esperion Therapeutics disclosed a conflict with Nexletol partner Daiichi Sankyo in an SEC filing earlier this month, the company has kicked it up a notch with a lawsuit claiming it's entitled to $300 million in milestone payments.
Shares of Esperion Therapeutics lost more than half their value Thursday morning on fears the company may not get a $300 million milestone payment from Daiichi Sankyo.
Primary endpoint met in the CLEAR Outcomes Trial of bempedoic acid showing statistically significant relative risk reduction in major adverse CV events
ANN ARBOR, Mich., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial met its primary endpoint, demonstrating statistically significant risk reduction in MACE-4 in patients treated with 180 mg/day NEXLETOL compared to placebo.