Cath Lab DigestUS FDA Approves First Anti-Inflammatory Drug for Cardiovascular Disease

In adult patients with established atherosclerotic cardiovascular disease (ASCVD), LODOCO® (colchicine, 0.5 mg tablet) reduces the risk of a cardiac event by an additional 31% over standard of care.

AGEPHA Pharma USA, LLC, achieves a significant breakthrough as the FDA greenlights LODOCO®, a first-of-its-kind, anti-inflammatory atheroprotective cardiovascular drug that aims to decrease the risk of various cardiovascular complications in adults with established atherosclerotic disease or numerous cardiovascular risk factors.

Key Points:

• The FDA has granted approval to AGEPHA Pharma’s LODOCO, an anti-inflammatory atheroprotective cardiovascular medication, after a priority review.
• LODOCO is the first drug of its kind, shown to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic disease or numerous cardiovascular risk factors.
• LODOCO can be used alone or in combination with medications that lower cholesterol. It targets residual inflammation, which is an underlying cause of ASCVD.
• Randomized trial data supporting LODOCO’s efficacy and safety are published in several prestigious medical journals, including the New England Journal of Medicine, Circulation, and The Lancet.

Additional Points:

• The clinical trial that demonstrated LODOCO’s efficacy was a multi-national, randomized, double-blind, placebo-controlled study conducted with 5,522 patients with chronic coronary disease.
• Inflammation, along with high cholesterol, is now recognized as a crucial factor increasing cardiovascular risks.
• LODOCO has been proven to substantially reduce the risks of recurrent heart attack and stroke in appropriate patients already on statins.
• The drug operates by inhibiting microtubule assembly and has multiple anti-inflammatory mechanisms.

Conclusion:

• The approval of LODOCO represents a significant step forward in patient care and ushers in a new era in the management of cardiovascular disease by directly addressing inflammation in addition to high cholesterol.

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Did You Know?
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of morbidity and mortality in the United States, with more than 2 million hospitalizations and 400,000 deaths annually.