Regulatory FDA Gives Green Light to Agepha Pharma’s Heart Disease...

FDA Gives Green Light to Agepha Pharma’s Heart Disease Drug


Colchicine was first used as a treatment for inflammation in Egypt more than 3500 years ago. Subsequent research revealed that it was also beneficial against a wide range of other conditions, such as gout, dropsy, and familial Mediterranean fever.

Now, the age-old treatment, which can be found in plants such as wild saffron and autumn crocus, has a more contemporary application: the FDA has given the green light for it to be used as the first medicine that specifically targets cardiovascular inflammation.

Agepha Pharma, a 76-year-old family-owned business with its headquarters in Slovakia, has been granted approval by the FDA. The corporation, which mostly operates in Europe, will make its debut in the U.S. with this launch.

Patients who have atherosclerotic disease or numerous risk factors for cardiovascular disease may see a reduction in their risk of stroke, coronary revascularization, myocardial infarction, and mortality from cardiovascular disease when the 0.5-mg, once-daily pill dubbed Lodoco is coupled with statins. 

Agepha’s Managing Director, Antonia Riel-Kollman, remarked, “It has been long understood that inflammation as well as high cholesterol increases cardiovascular risks. 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.”

The author of the study, Paul Ridker, M.D., of Harvard Medical School, stated that vascular inflammation plays a role in the creation of plaque. He claims that the high-sensitivity C-reactive protein (hsCRP) indicator may determine whether or not inflammation is present in the body.

At the American College of Cardiology conference held in New Orleans in March, Ridker said that without measuring CRP, it’s essentially impossible to determine whether the patient has this issue, so physicians must understand that a large variety of heart diseases are being ignored.

The approval centred on a study that involved 5,522 individuals with persistent coronary disease who were already receiving high-intensity statins. Researchers tested lodoco against a placebo and found that Lodoco reduced the risk of stroke and death from cardiovascular disease by 31% compared to it.

Lodoco is on Agepha’s launch schedule for the second half of this year, but the company has not disclosed pricing information for the medication just yet.

The FDA approved colchicine for human use in 1961, long before it had the ability to ensure the drug’s safety. URL Pharma was the only one of over a dozen businesses selling generic colchicine to perform a clinical trial for the medicine in 2007, when the Unapproved Drug Initiative mandated safety testing for some marketed therapies.

After receiving FDA clearance for Colcrys, the company increased the price from $0.09 to $5 per dosage, turning it into a major cash cow. Takeda, which spent $800 million to acquire URL in 2012, made $542 million off of Colcrys in 2014, the last year before generic medications hit the market.

More than a decade ago, Agepha obtained a patent for using colchicine as a treatment for cardiovascular disease. In the past year, scientists have also looked into colchicine as a possible therapy for COVID-19.

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