FDA Approves Colchicine as breakthrough for lowering CVD events

USA: Colchicine 0.5 mg (to be sold as Lodoco) has been approved by the US Food and Drug Administration (FDA), making it the first anti-inflammatory drug indicated for reducing cardiovascular events in individuals, announced by Agepha Pharma.

Antonia Riel-Kollmann, managing director of Agepha Pharma, said, “Traditionally, colchicine has been used for treating gout but now reformulated as Lodoco specifically with no generic alternatives for long-term use in cardiovascular disease patients.”

Lodoco is the first of its kind, offering a novel clinical approach to managing cardiovascular risk. It can be taken once daily, alone or in combination with standard lipid-lowering therapies. The company added that the drug is expected to be available for prescription later this year, providing a new option for physicians and patients.

In the LoDoCo2 trial, a randomized, double-blind, placebo-controlled study involving over 5,000 patients with chronic coronary disease, Patients already receiving guideline-directed medical therapy experienced a reduction in the primary endpoint (cardiovascular death, nonprocedural myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization) when colchicine was added to their treatment regimen. Over a median follow-up period of 28.6 months, the colchicine group exhibited a lower incidence of cardiovascular events (6.8% vs 9.6%) than the placebo group.