Lodoco FDA Approval History
Last updated by Judith Stewart, BPharm on June 20, 2023.
FDA Approved: Yes (First approved June 16, 2023)
Brand name: Lodoco
Generic name: colchicine
Dosage form: Tablets
Company: AGEPHA Pharma USA, LLC
Treatment for: Cardiovascular Risk Reduction
Lodoco (colchicine) is an alkaloid indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.
- Colchicine is an alkaloid derived from the Colchicum autumnale plant that has been used for centuries for the treatment of joint pain and gout. In more recent years, colchicine has been approved by the FDA under the brand names Colcrys for the treatment and prophylaxis gout flares, and the treatment of Familial Mediterranean fever; and Mitigare and Gloperba for the prophylaxis of gout flares.
- Lodoco is the first FDA approved drug that targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease (ASCVD). ASCVD is a condition where the arteries become narrowed and hardened due to the buildup of plaque, which can lead to heart attacks and strokes. Inflammation is thought to play a substantial role in the formation of atherosclerotic plaque.
- The exact mechanism of action of colchicine in reducing residual inflammatory risk is not clearly understood, but it is thought to suppress local cardiac production of inflammatory cytokines IL-1β, IL18, and IL-6 in patients with coronary artery disease. It may also inhibit the infiltration of neutrophils and macrophages and attenuate the mRNA expression of pro-inflammatory cytokines and NLRP3 inflammasome components in the infarcted myocardium.
- Lodoco tablets are taken orally once a day.
- Warnings and precautions associated with Lodoco include blood dyscrasias and neuromuscular toxicity.
- Common adverse reactions include diarrhea, vomiting, abdominal cramping, and myalgia.
Development timeline for Lodoco
| Date | Article |
|---|---|
| Jun 20, 2023 | Approval FDA Approves Lodoco (colchicine) as the First Anti-Inflammatory Drug for Cardiovascular Disease |
Further information
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