First: FDA approves low dose Colchicine for reduction of CV events in high risk patients
USA: Colchicine 0.5 mg (Lodoco) has received US FDA (Food and Drug Administration) approval as the first anti-inflammatory indicated for reducing cardiovascular (CV) events in adults with established ASCVD (atherosclerotic cardiovascular disease) or who are at risk of developing it. It reduces the risk of stroke, myocardial infarction (MI), coronary revascularization, and cardiovascular death.
AGEPHA Pharma revealed that LODOCO (colchicine, 0.5 mg tablet) reduced cardiac event risk in adult patients with established ASCVD by an additional 31% on top of the standard of care. According to the company, Lodoco will be available for prescription in the second half of 2023.
The safety and effectiveness of LODOCO in preventing stroke and heart attack are supported by randomized trial data published in the Journal of the American College of Cardiology, New England Journal of Medicine, European Heart Journal, and Circulation. Data emphasizing the critical need to address inflammation as much as cholesterol in heart disease patients has been recently described in The Lancet.
The multi-national, placebo-controlled, double-blind, randomized clinical trial was conducted among 5,522 patients with chronic coronary disease, all of home were taking guideline-directed medical care, including high-intensity statins.
The trial showed that 0.5 mg colchicine, when added to high-intensity statin and other cardiology prevention therapies, significantly reduced the overall risk of spontaneous myocardial infarction, cardiovascular death, ischemia-driven coronary revascularization, or ischemic stroke in comparison with the placebo group (hazard ratio [HR], 0.69).
Inflammation plays a vital role in Atherosclerotic Cardiovascular Disease, where the arteries become hardened and narrowed due to plaque buildup, leading to stroke and heart attacks. ASCVD refers to conditions including cerebrovascular disease, peripheral artery disease, acute coronary syndrome, and coronary artery disease.
Inflammation plays a substantial role in the formation of atherosclerotic plaque, contributing to the development and progression of ASCVD. LODOCO inhibits microtubule assembly and has multiple anti-inflammatory mechanisms. High-sensitivity C-reactive protein (hs-CRP) is the inflammatory biomarker most widely used to predict residual inflammatory risk and ASCVD outcome.
Michael Blaha, MD, MPH, director of clinical research and professor of medicine at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, said, "For the first time, patients with residual inflammatory risk, as measured by hs-CRP, will have an FDA-approved treatment option demonstrated to reduce the risk of cardiovascular disease by targeting the inflammatory pathways that influence major cardiac events."
Dr Blaha added, "The cardiovascular research community has demonstrated that focusing on unmet patient medical needs and addressing the long-standing challenge of reducing cardiac inflammation can translate into meaningful risk reduction in the incidence of cardiac events."
About LODOCO
LODOCO tablets are formulated as a once-daily, continuous-use oral treatment for adults. They can be used safely alone or in combination with standard-of-care lipid-lowering medications and other therapies to effectively reduce the risk of heart attack and stroke.
Patients with kidney failure or severe liver disease should not take LODOCO. Patients should temporarily stop taking LODOCO if prescribed certain drugs like ketoconazole or azithromycin, or these medications should not be taken simultaneously.
