Agepha Pharma made a bit of history when Lodoco, the company’s version of colchicine, became the first anti-inflammatory drug approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of myocardial infarction, stroke and other significant cardiovascular events.
Cardiologists, especially those in the field of preventive cardiology, have applauded the approval, but one question remains: How much will Lodoco cost?
According to Steve Andrzejewski, Agepha Pharma’s head of U.S. operations, the company is still working to finalize a price.
“A potentially life-saving medication can only save lives if it’s accessible to those with diagnosed medical needs, which is why our pricing strategy for Lodoco is focused on helping to ensure access to as many people as possible,” he told Cardiovascular Business. “The exact price of Lodoco has not been determined.”
Andrzejewski did confirm that Agepha Pharma is working to develop a “patient assistance program” for those who may not be able to afford the newly approved drug. Once that program is live, he said, interested parties should be able to enroll online and learn more about their options.
‘Large and sharp’ price increases have plagued colchicine in the past
Colchicine was at the center of a significant price hike in 2010. At the time, the drug was known as a recommended treatment for gout.
A recent study in JAMA Internal Medicine explored the situation at length, showing the price per colchicine prescription increased from $11.25 in 2009 to $190.49 in 2011. As one might expect, this was linked to a dramatic decline in the use of colchicine.
“The study’s findings suggest that the large and sharp increase in colchicine prices was associated with a sustained decrease in colchicine use, increased use of other medications for gout, and increased clinical encounters for gout, consistent with poorer disease control,” wrote lead author Dan P. Ly, MD, PhD, MPP, with the University of California Los Angeles, and colleagues.
What’s next for Agepha Pharma and Lodoco?
With the FDA’s approval in place, Agepha Pharma is now focused on launching the medication and reaching high-risk heart patients.
“The next big step for Lodoco is bringing the drug to the hands of patients,” Andrzejewski said. “Our team is looking forward to delivering Lodoco to patients in need as quickly as possible.”
Agepha Pharma hopes to have colchicine/Lodoco available for prescription use by the second half of 2023.
Andrzejewski also noted that he and his colleagues have appreciated the healthcare industry’s positive reaction to this noteworthy approval.
“We appreciate how big of a step forward this was for the care of patients with CVD and those at risk of developing it,” he said. “We are hopeful that the conversations continue to further raise awareness of cardiovascular inflammation and Lodoco as a potential solution.”