Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean fever.
Now, the ancient therapy—found in plants including wild saffron and autumn crocus—has a more modern use: It has been approved by the FDA as the first drug to target cardiovascular inflammation.
Agepha Pharma, a 76-year-old, family-owned company based in Dubai, has scored the FDA nod. This will be the first launch in the U.S. for the European-centric company, which was founded in Austria.
When combined with statins, the 0.5-mg, once-daily tablet—which has been branded as Lodoco—reduces the risk of stroke, coronary revascularization, myocardial infarction and cardiovascular death in patients with atherosclerotic disease or with multiple risk factors for cardiovascular disease.
“It has been long understood that inflammation as well as high cholesterol increases cardiovascular risks,” Antonia Riel-Kollmann, the managing director of Agepha, said in an email interview with Fierce Pharma. “A recent study in The Lancet demonstrated that among contemporary statin-treated patients, vascular inflammation strongly predicts future cardiovascular events—perhaps even more than high cholesterol.”
Paul Ridker, M.D., of Harvard Medical School, who authored the study, has noted that vascular inflammation contributes to the formation of plaque. He's said that the presence of inflammation can be measured by the high-sensitivity C-reactive protein (hsCRP) biomarker.
“If you’re not measuring CRP, you have no idea if the patient has this problem. Physicians need to recognize there’s a big chunk of [heart] disease that we are systematically ignoring,” Ridker said in March at the American College of Cardiology conference in New Orleans.
The approval is backed by a trial of 5,522 patients with chronic coronary disease who were already taking high-intensity statins. Lodoco was found to reduce the risk of stroke and cardiovascular death by 31% compared to placebo.
Agepha plans to launch Lodoco in the second half of this year and has yet to indicate what it will charge for the treatment.
Colchicine was licensed for use by the FDA in 1961, predating the regulator’s authority to oversee its safety. In 2007, when the Unapproved Drug Initiative required some marketed treatments to undergo safety testing, URL Pharma was the only company—out of more than a dozen that sold generic colchicine—to conduct a clinical trial for the drug which then sold for pennies.
After URL gained approval for Colcrys, the company jacked its price from $0.09 to $5 per dose and it became a significant moneymaker. Takeda, which acquired URL for $800 million in 2012, recorded $542 million in sales of Colcrys in 2014, before it became subject to generic competition.
Colchicine was first considered a potential remedy for heart disease more than a decade ago, leading Agepha to obtain a patent for its use in the indication. Last year, colchicine also was investigated as a treatment for COVID-19.