Agepha Pharma’s Lodoco (colchicine) just became the first anti-inflammatory drug to land FDA approval for reducing cardiovascular event risks, marking a major milestone in the emerging field of CVD inflammation treatment.
- The once-daily 0.5 mg tablet is approved for risk reduction of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established ASCVD or with multiple cardiovascular disease risk factors.
Lodoco can be used alone, but it’s expected to mainly be prescribed to patients who are already taking cholesterol-lowering medications and experienced a previous heart attack or stroke. If these patients’ high-sensitivity CRP tests show that their inflammation isn’t controlled, they might be even more likely to receive Lodoco.
- Lodoco’s FDA approval is largely based on the LoDoCo2 trial, which showed that colchicine reduced CV death and MACE risks by 31% compared to placebo among a similar group of patients.
- Colchicine has also earned spots in the European and South American CVD guidelines, and has Health Canada approval for atherothrombotic risk reduction among adults with CAD.
Colchicine might ring a bell to some readers, since it’s been used to treat gout, pericarditis, and familial Mediterranean fever (in 0.6 mg tablets). However, Lodoco has reportedly been reformulated for long-term CVD treatment, and there’s no generic colchicine alternatives for CVD.
Lodoco’s role as the first anti-inflammatory for CVD risk reduction might prove to be a significant milestone, given the mounting evidence that inflammation is an independent contributor to ASCVD and CV events, and what appears to be growing business and academic interest in treating CVD inflammation.
- That said, the significance of Lodoco’s FDA approval will depend on how widely it’s adopted, requiring a strong commercialization push by Agepha, as well as Lodoco’s real world performance earning the trust of physicians and cardiology societies.
It’s widely understood that inflammation contributes to ASCVD and drives CV events, and now for the first time US physicians have a way to treat CVD inflammation. That makes Lodoco’s FDA approval a significant milestone, and could make its future support by guidelines, physicians, and payors even more significant milestones.