U.S. FDA Approves First Anti-Inflammatory Drug for Cardiovascular Disease

PARSIPPANY, N.J.– AGEPHA Pharma USA, LLC, today announced that, following a Priority Review, the U.S. Food and Drug Administration (FDA) has approved LODOCO® as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.¹

AGEPHA Pharma anticipates that LODOCO, which can reduce the risk of cardiac events in patients with established cardiovascular diseases by 31%² on top of standard of care, will be available for prescription in the second half of 2023.

Clinical Evidence of LODOCO for Heart Attack and Stroke Prevention

The effectiveness and safety of LODOCO in preventing heart attack and stroke is supported by randomized trial data reported in the New England Journal of Medicine, Circulation, Journal of the American College of Cardiology, and European Heart Journal, while 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, 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. In the trial, 0.5 mg colchicine was found to significantly reduce 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 [HR], 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001).²

Entering a New Era of Patient Care

It has been long understood that inflammation as well as high cholesterol increases cardiovascular risks.

“Approval by the FDA of the first drug to target cardiovascular inflammation is an important step forward for the care of our patients,” said Paul Ridker, MD, MPH, professor of medicine, Harvard Medical School and director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital, who has been instrumental in elucidating the role of inflammation in cardiovascular disease. Dr. Ridker added, “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.”

A recent study in The Lancet, on which Dr. Ridker served as lead author, demonstrated that among contemporary statin-treated patients, vascular inflammation strongly predicts future cardiovascular events – perhaps even more than high cholesterol.

Reduce Inflammation, Reduce Plaque Formation

Inflammation plays a critical role in Atherosclerotic Cardiovascular Disease (ASCVD). ASCVD is a condition where the arteries become narrowed and hardened due to the buildup of plaque, which can lead to heart attacks and strokes³ and refers to conditions including coronary artery disease, acute coronary syndrome, peripheral artery disease, and cerebrovascular disease. Patients with ASCVD, the leading cause of morbidity and mortality in the United States⁴, are at high risk for acute cardiovascular events.⁵

The formation of atherosclerotic plaque, in which inflammation plays a substantial role, contributes to the development and progression of ASCVD.⁶ LODOCO inhibits microtubule assembly and has multiple anti-inflammatory mechanisms.^7,8 High-sensitivity C-reactive protein (hs-CRP) is the inflammatory biomarker most widely used to predict residual inflammatory risk and ASCVD outcomes.⁹

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.”

Disease burden in the United States