US EditionMerck's Oral Cholesterol Pill Cuts LDL by 60% in Trial
Merck’s oral PCSK9 inhibitor enlicitide reduced LDL cholesterol by about 60% after 24 weeks and sustained reductions through one year in a trial of 2,912 adults with or at risk for ASCVD.
- On Saturday at the American Heart Association meeting, Merck, pharmaceutical company, reported enlicitide reduced LDL by up to 60% after 24 weeks in a phase 3 trial of 2,912 adults.
- Amid widespread under‑treatment of LDL cholesterol, about 70 patients on lipid‑lowering therapies do not reach guideline goals, and PCSK9 injectables face barriers with list prices over $500 a month.
- Merck reported that safety signals were similar, with about 10% of enlicitide patients experiencing serious adverse events and Dr. Puja Banka stating `Ultimately, the side effects were balanced between the enlictide arm and the placebo arm`.
- Merck plans to apply to the US Food and Drug Administration for enlicitide early next year and aims to launch the drug in 2027 while making it affordable to 'democratize PCSK9' access.
- A larger outcomes study of more than 14,500 people is underway as PCSK9 blockade can reduce heart attacks and strokes by up to 20%, with at least 6 million adults in the United States eligible.
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31 Articles
Merck's Enlicitide Shows Promising Results In Phase 3 CORALreef Lipids Trial
(RTTNews) - Merck & Co Inc. (MRK) has unveiled the first results from its pivotal Phase 3 CORALreef Lipids trial, highlighting the efficacy of enlicitide decanoate, an investigational once-daily oral PCSK9 inhibitor. The treatment demonstrated a statistically significant and clin
Local 3 News
For some people with high cholesterol, making lifestyle changes and routinely taking statins medications may not be enough to reach their target cholesterol levels. For these patients, a new experimental pill might be able to...
By Jacqueline Howard, CNN. For some people with high cholesterol, making lifestyle changes and routinely taking statin medications may not be enough to reach their target cholesterol levels. For these patients, a new experimental pill could offer some hope. Data from a phase 3 trial found that people who took the investigational drug enlicitide along with their usual cholesterol-lowering regimen, such as statins, experienced up to a 60% reductio…
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