Agepha Pharma

EMA: CHMP Positive Opinion: Colchicine Agepha Pharma

CHMP issued a positive opinion for Colchicine Agepha Pharma to reduce myocardial infarction, stroke, coronary revascularization, and cardiovascular death risk in people with atherosclerotic disease or multiple cardiovascular risk factors on May 21, 2026. This represents a new marketing authorization application for the anti-inflammatory drug in cardiovascular prevention. Agepha Pharma gains access to the growing European cardiovascular prevention market, competing against established lipid-lowering therapies and newer anti-inflammatory approaches. The approval follows established precedent from colchicine's proven cardiovascular benefits in landmark trials.