FDA Approves First Anti-inflammatory Drug for Cardiovascular Disease

The FDA has approved Lodoco (colchicine) to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients. Developed by Agepha Pharma, Lodoco is the first drug approved to target inflammation that is an underlying cause of atherosclerotic cardiovascular disease. It can be used alone or in combination with cholesterol-lowering medications.

Colchicine is a well-established molecule and generic colchicine that is used at high doses for the treatment of gout. Lodoco has been reformulated in a lower dose specifically for long-term use in cardiovascular disease patients. Lodoco 0.5 mg tablets are a once-daily tablet and will be available in the second half of 2023.

An exact price hasn’t been determined, but Antonia Riel-Kollmann, managing director of Agepha Pharma, told Formulary Watch that the pricing strategy will be focused on helping to ensure access to as many people as possible. “We’re planning to offer a patient assistance program to help ensure access to those patients who can’t afford Lodoco,” he said.

Inflammation plays a critical role in atherosclerotic cardiovascular disease (ASCVD), a condition where the arteries become narrowed and hardened due to the buildup of plaque, which can lead to heart attacks and strokes. An analysis of three studies recently published in The Lancet found that among patients receiving statins, inflammation was a stronger predictor for risk of future cardiovascular events and death than cholesterol assessed by low-density lipoprotein cholesterol.

Paul Ridker, M.D.

“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,” lead author of The Lancet paper Paul Ridker, M.D., MPH, professor of medicine, Harvard Medical School and director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital, said in a press release.

The approval was based on a clinical trial with 5,522 patients with chronic coronary disease, which was published in Circulation in February 2022. In the trial, Lodoco 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. Over five years, Lodoco produced a consistent reduction in major cardiovascular events.