Relief for Americans with foot wounds caused by diabetes might come from an unlikely place: Cuba.
A U.S. biotech company received Food and Drug Administration approval recently to run a clinical trial in America for Heberprot-P, a drug developed in Cuba nearly two decades ago that helps heal diabetes foot ulcers that could otherwise lead to amputation.
Why it matters: About 1 in 3 people with diabetes develop a foot ulcer during their lives, according to an article last year in JAMA. In the U.S., 1.6 million people are affected. About half of diabetic foot ulcers become infected, and 1 in 5 of those lead to amputation.
“There’s really nothing in America to treat these diabetic foot ulcers,” said Lee Weingart, a former Ohio county commissioner and current lobbyist who co-founded Discovery Therapeutics Caribe, which will run the clinical trial for the Cuban drug.
Heberprot-P reduced amputations by 72 percent in foreign studies, he told an audience at a recent event promoting the island’s biotech at the Cuban embassy in Washington.
The drug is available in more than two dozen other countries, but the decades-old U.S. sanctions on Cuba have hindered its path to America.
However, former President Barack Obama in 2016 allowed U.S. and Cuban organizations to cooperate on medical projects, which underpins the effort to bring the Cuban drug to the U.S., according to Weingart.
What’s next? Weingart hopes to have it on the U.S. market by the end of 2028 after running the clinical trial, which will enroll about 180 people nationwide.
The FDA didn’t question any clinical data from seven Cuban clinical trials, so Discovery Therapeutics needs only to prove the drug is safe, he said.
The Cuban Window 