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A long-used, repurposed anti-inflammatory therapy has won backing from the European panel as a hybrid application for cardiovascular prevention in stable coronary disease.

At its May meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorization for Colchicine Agepha Pharma for the secondary prevention of atherothrombotic events in adults with coronary disease that has been stable for at least 6 months. 

Colchicine Agepha Pharma is a hybrid of Colchicine Tiofarma 0.5 mg tablets, which have been authorized in the European Union since 1998. Colchicine Agepha Pharma contains the same active substance as the reference product but differs in its proposed cardiovascular indication.

If authorized by the European Commission, the medicine would offer clinicians another option to reduce atherothrombotic risk in this population.

This decision marks the first time an anti-inflammatory therapy has been authorized for cardiovascular prevention within the European Union.

About the Inflammation Blocker

Colchicine Agepha Pharma will be available as 0.5 mg tablets. The active substance is colchicine, an anti-inflammatory medicine classified by EMA as an antigout preparation with no effect on uric acid metabolism.

Colchicine exerts its cardiovascular effects through anti-inflammatory pathways, including inhibition of granulocyte migration to inflamed areas, inhibition of microtubule polymerization, and modulation of inflammatory pathways implicated in atherosclerosis.

The product applicant is Agepha Pharma s.r.o. in Slovakia.

Evidence Behind the Recommendation

The decision is supported by clinical evidence showing cardiovascular risk reduction with low-dose colchicine in patients with stable coronary disease. The EMA announcement stated that Colchicine Agepha Pharma significantly reduced the time to first occurrence of cardiovascular death, spontaneous myocardial infarction (MI), ischemic stroke, or ischemia-driven coronary revascularization compared with placebo in a randomized study of patients with stable coronary artery disease for at least 6 months.

The agency also noted that studies demonstrated the satisfactory quality of Colchicine Agepha Pharma and its bioequivalence to the reference product Colchicine Tiofarma.

The broader clinical evidence base includes two trials. The COLCOT trial enrolled 4745 patients who had experienced an MI within 30 days. Patients received either low-dose colchicine 0.5 mg once daily or placebo for a median of 22.6 months. The primary endpoint (a composite of CV death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization) occurred in 5.5% of patients in the colchicine group compared with 7.1% in the placebo group, representing a 23% relative risk reduction for CV events (P = .02).

The phase 3 LoDoCo2 trial further validated colchicine’s cardiovascular benefits in patients with chronic coronary disease. This study randomly assigned 5522 patients to receive 0.5 mg colchicine once daily or placebo for a median of 28.6 months. The primary composite endpoint (a composite of CV death, nonprocedural myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization) occurred in 6.8% of patients in the colchicine group vs 9.6% in the placebo group, demonstrating a 31% relative risk reduction for CV events (P < .001). 

Safety Concerns

The most common side effects include gastrointestinal disorders such as diarrhea, nausea, vomiting, abdominal pain, and cramping. 

In the COLCOT trial, diarrhea was reported in 9.7% of patients receiving colchicine compared with 8.9% of patients on placebo. Pneumonia occurred as a serious adverse event in 0.9% of patients receiving colchicine vs 0.4% of patients on placebo.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published on the EMA website in all official European Union languages after marketing authorization has been granted by the European Commission.