FDA approves first anti-inflammatory cardiovascular drug

June 21, 2023

The U.S. FDA has approved Agepha Pharma's Lodoco (colchicine) tablets — the first approved drug to target cardiovascular inflammation and the company’s first product launch in the U.S.

In trials, the company's anti-inflammatory atheroprotective cardiovascular treatment reduced the risk of myocardial infarction, stroke, coronary revascularization and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Lodoco tablets are formulated as a once-daily, continuous-use oral treatment for adults and can be used safely alone or in combination with standard-of-care lipid-lowering medications and other therapies. According to the Slovakia-based company, Lodoco can reduce the risk of cardiac events in patients with established cardiovascular diseases by 31% on top of standard of care.

Agepha, a family-owned and operated 70+ year old company, has over 50 products approved in Europe. Lodoco, its first U.S. product, will hit the market in the second half of 2023.