FDA approves anti-inflammatory drug for patients with established or risk of CVD

The FDA has approved colchicine as the first anti-inflammatory drug for the treatment of CVD. Colchicine is indicated to reduce the risk of MI, stroke, coronary revascularization and CV mortality in adult patients with established ASCVD or with multiple CVD risk factors.

This approval is based on the findings of the LoDoCo2 trial, in which the safety and efficacy of colchicine (0.5 mg once daily) was examined in adult patients (n=5522) with proven coronary disease. In LoDoCo2, colchicine reduced the risk of MI, stroke, coronary revascularization or CV mortality by 31% compared to placebo when added to standard care in patients with established ASCVD.

Colchicine is available as an oral tablet and can be safely used alone or in combination with lipid-lowering medications and other therapies. Colchicine should not be used by patients with kidney failure or severe liver disease.

Source: press release AGEPHA Pharma, June 20, 2023