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.

Leading cardiologist Dr Paul M. Ridker, the principal investigator for the LoDoCo2 trial, highlighted the synergistic effects of lowering cholesterol and inhibiting inflammation. He also said colchicine treatment is unsuitable for individuals with severe kidney or liver disease due to potential complications. However, it will benefit patients with high residual inflammatory risk, determined by elevated levels of high-sensitivity C-reactive protein (CRP).

Dr Michael Blaha, MD, MPH (Johns Hopkins Medicine, Baltimore, MD), emphasized the intriguing potential of colchicine as a new tool in cardiovascular medicine. With multiple mechanisms of action available to reduce cardiovascular risks, it becomes challenging for clinicians to determine how these interventions can be combined to optimize patient outcomes.

“The exact pricing for Lodoco is yet to be determined; Agepha Pharma intends to address the concern of those patients who cannot afford the medication by offering a patient-assistance program”,- said the director of Agepha Pharma.

References:

Agepha Pharma USA. U.S. FDA approves first anti-inflammatory drug for cardiovascular disease. Published and accessed on: June 20, 2023.