Agepha Pharma’s Lodoco Anti-Inflammatory Drug for Cardiovascular Disease Approved by FDA

June 20, 2023—Agepha Pharma USA, LLC, announced FDA approval of Lodoco (colchicine) as an anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. The approval comes after a Priority Review conducted by the FDA.

Lodoco tablets are formulated as a once-daily, continuous-use oral treatment for adults and 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.

The company anticipates that Lodoco will be available for prescription in the second half of 2023.

According to Agepha Pharma, 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 atherosclerotic cardiovascular disease outcomes.

Lodoco can reduce the risk of cardiac events in patients with established cardiovascular diseases by 31% on top of standard of care.

The company stated that the effectiveness and safety of Lodoco in preventing heart attack and stroke is supported by randomized trial data reported by Stefan M. Nidorf, MD, et al in The New England Journal of Medicine (NEJM; 2020;383:1838-1847); Tjerk S.J. Opstal, MD, et al in Circulation (2022;145:626-628); Tjerk S.J. Opstal MD, et al in Journal of the American College of Cardiology (2021;78:859-866); and Aernoud T. L. Fiolet, MD, et al in European Heart Journal (2021;42:2765–2775).

The multinational, randomized, double-blind, placebo-controlled clinical trial was conducted among 5,522 patients with chronic coronary disease, all of whom were taking guideline-directed medical care including high-intensity statins.

As reported by Nidorf et al in NEJM, the trial found that 0.5 mg colchicine significantly reduced the overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization by 31% in comparison with the placebo group when added to high-intensity statins and other cardiology prevention therapies (hazard ratio, 0.69; 95% CI, 0.57-0.83; P < .001).

Data emphasizing the critical need to address inflammation as much as cholesterol in heart disease patients were recently described by Paul M. Ridker, MD, et al in The Lancet (2023;401:1293-1301).

The company noted that Dr. Ridker has been instrumental in elucidating the role of inflammation in cardiovascular disease. He is professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, Massachusetts.

“Approval by the FDA of the first drug to target cardiovascular inflammation is an important step forward for the care of our patients,” commented Dr. Ridker in the company’s press release. “To treat coronary disease effectively, cardiologists must aggressively reduce inflammation and cholesterol. For appropriate patients already taking a statin, adding the anti-inflammatory drug colchicine at a dose of 0.5 mg daily has been proven to significantly lower risks of recurrent heart attack and stroke.”

In the study in The Lancet, Dr. Ridker and colleagues demonstrated that among contemporary statin-treated patients, vascular inflammation strongly predicts future cardiovascular events—perhaps even more than high cholesterol, advised the company.

Michael Blaha, MD, MPH, who is Director of Clinical Research and Professor of Medicine at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease in Baltimore, Maryland, stated in Agepha Pharma’s press release, “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.”