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EMA committee adopts positive opinions for label update of both bempedoic acid and bempedoic acid/ezetimibe FDC to reduce LDL─C & cardiovascular risk
26 Mar 2024 10:06 GMT
… with additional ezetimibe treatment or, in patients who are either statin-intolerant, or … the phase 3 CLEAR Outcomes trial demonstrated: a 13% reduction in … discover, develop, and commercialize innovative medicines to help improve outcomes for …
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FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use
25 Mar 2024 20:44 GMT
… ® (bempedoic acid and ezetimibe) Tablets based on positive … statins of first choice within the cardiovascular risk reduction treatment … statin LDL-C lowering drugs to be approved by the FDA … special offers
from American Pharmaceutical Review – all delivered …
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Clinical Quiz: Non-Statin Therapies for LDL-C Lowering
25 Mar 2024 18:37 GMT
In LDL-C management, statins have remained a cornerstone … profile, many patients are statin-intolerant and require a more … bempedoic acid and combination with ezetimibe, have proven to be reliable … knowledge on use of non-statin therapies for lowering LDL- …
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Esperion snags US label expansion for cardiovascular disease drugs
25 Mar 2024 15:58 GMT
… Nexlizet (bempedoic acid and ezetimibe).
The two once-daily, … with statins. The upgraded label also includes treatment for … LDL-C lowering non-statin drugs indicated for primary … two clinical trials (NCT02666664 and NCT02991118).
The FDA approval was …
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Esperion Targets Seven-Fold Jump in Cholesterol Drug Population with FDA Label Expansion
25 Mar 2024 13:43 GMT
… FDA labels for its cholesterol-busting drugs Friday, clearing the biotech … of the rival drugs Zetia (ezetimibe), Repatha (evolocumab … statins of first choice within the cardiovascular risk reduction treatment … a freelance pharmaceutical and biotech writer based …
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FDA expands label for Esperion's Nexletol, Nexlizet to cover heart attack, cardiovascular procedures
25 Mar 2024 11:04 GMT
… major FDA label expansions for its two cholesterol-lowering drugs, … patients, regardless of statin use. Both pills contain bempedoic acid, … combination with another cholesterol-lowering drug, ezetimibe.
Unlock this article instantly …
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NewAmsterdam Pharma to Present New Analysis from the Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe at 2024 American College of Cardiology Congress
25 Mar 2024 12:00 GMT
… company developing oral, non-statin medicines for patients at risk of … 3 clinical trial to evaluate obicetrapib and ezetimibe FDC (‘fixed … of current LDL-lowering treatments. The Company believes that … ”) in NewAmsterdam’s clinical trials to date. The Company …
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Esperion: FDA Approves Expanded Labels For NEXLETOL And NEXLIZET Tablets
23 Mar 2024 10:09 GMT
… S. Food and Drug Administration or FDA approved new label … and NEXLIZET (bempedoic acid and ezetimibe) Tablets.
The U.S. … trial, which was published in the New England Journal of Medicine … LDL-C lowering non-statin drugs indicated for primary prevention …
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A Combined Measure of the Triglyceride Glucose Index and Trimethylamine N-Oxide in Risk Stratification of ST-Segment Elevation Myocardial Infarction Patients with High-Risk Plaque Features Defined by Optical Coherence Tomography: A Substudy of the…
29 Mar 2024 06:30 GMT
… Hospital OCTAMI Registry, clinical trials.gov: NCT03593928).
Definition … Diseases, Peking Union Medical College, China.
Acknowledgments … et al. Ezetimibe added to statin therapy after acute … trimethylamine production for the treatment of atherosclerosis. Cell …
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Esperion Announces Data from CLEAR Outcomes Sub-Groups as Poster Presentations, Moderated Session & Industry Expert Theatre to be Presented at ACC.24
25 Mar 2024 20:00 GMT
… for Statin-Intolerant Women Receiving Bempedoic Acid in the CLEAR Outcomes Trial … , MPH; Stanford Cardiovascular Institute, Stanford Medicine, Stanford, California
Title:
Bempedoic … and NEXLIZET® (bempedoic acid and ezetimibe) Tablet. The CLEAR Program …