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Colchicine receives FDA approval for cardiovascular disease

Colchicine has become the first anti-inflammatory agent to be approved by the US Food and Drug Administration (FDA) for the treatment of cardiovascular disease (CVD).

According to the Europe-based manufacturer, Agepha Pharma, the FDA has approved colchicine 0.5 mg as the first anti-inflammatory athero-protective cardiovascular treatment, for patients either with established CVD or with multiple risk factors for the disease.

While both inflammation and hypercholesterolaemia jointly contribute to atherothrombotic disease, an analysis published in The Lancet in 2023, found that in patients receiving statins, inflammation was a stronger predictor for risk of future cardiovascular events and death than cholesterol. Colchicine achieves a beneficial effect in CVD at the cellular level through several mechanisms that include inhibition of endothelial cell dysfunction and inflammation, smooth muscle cell proliferation and migration, macrophage chemotaxis, migration, adhesion and platelet activation. 

Colchicine in patients with CVD

Evidence that colchicine is effective in CVD comes from a large study published in the New England Journal of Medicine. Over 5,000 patients with chronic coronary disease were randomised to colchicine 0.5 mg daily or matching placebo. The primary endpoint for the trial was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischaemic stroke or ischaemia-driven coronary revascularisation.

After a median of 28.6 months, significantly fewer patients assigned to colchicine experienced a primary endpoint event (hazard ratio, HR = 0.69, 95% CI 0.57 – 0.83, p < 0.001). Other work has also revealed how colchicine is effective in patients with chronic coronary disease both prior to and following an acute coronary syndrome.

Commenting on the approval, Paul Ridker, a consultant for Agepha Pharma as well as professor of medicine at Harvard Medical School and director of the Centre for Cardiovascular Disease Prevention, Brigham and Women’s Hospital, said: ‘Approval by the FDA of the first drug to target cardiovascular inflammation is an important step forward for the care of our patients.

‘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.

Colchicine is formulated as a once-daily, continuous-use oral treatment for adults that can be used safely either alone or in combination with standard-of-care lipid-lowering medications to effectively reduce the risk of heart attack and stroke.

The manufacturer anticipates that it will be available for prescription in the US in the second half of 2023. Potential plans for gaining approval in the UK or EU are currently unknown.