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First adult anti-inflammatory cardiovascular drug approved

An FDA-approved anti-inflammatory drug can reduce cardiovascular disease risk by an additional 31 percent in adults, on top of standard of care, clinical data has shown.

First adult anti-inflammatory cardiovascular drug approved

The US Food and Drug Administration (FDA) has approved LODOCO®, the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital. It is the first anti-inflammatory cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for cardiovascular disease, according to AGEPHA Pharma, who developed the drug.

Approval of LODOCO follows a Priority Review granted by the US FDA.

Efficacy of the anti-inflammatory cardiovascular drug

The anti-inflammatory cardiovascular treatment LODOCO can reduce the risk of cardiac events in patients with ASCVD by 31 percent on top of standard of care, according to trial data published in The New England Journal of Medicine.

The clinical trial was conducted among 5,522 patients with chronic coronary disease. All were taking guideline-directed medical care including high-intensity statins at the time.

A 0.5mg dose of colchicine demonstrated a significantly reduced overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularisation, in comparison with the trial placebo group when added to high-intensity statins and other cardiology prevention therapies.

What is the mechanism of action for LODOCO?

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 outcomes, according to research highlighted by AGEPHA Pharma.

“For appropriate patients already taking a statin, adding the anti-inflammatory drug colchicine at a dose of 0.5mg daily has been proven to significantly lower risks of recurrent heart attack and stroke,” Dr Ridker added.

The once-daily LODOCO tablet treatment is expected to be available to adult US patients in the second half of 2023.

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