Cuban medicine receives authorization for clinical trial in the United States

The United States Food and Drug Administration (FDA) issued an authorization to carry out a clinical trial with the Cuban drug Heberprot-P.

The American company Discovery Therapeutics Caribe (DTC), specialized in biotechnology, announced that in the first quarter of 2024, it submitted a request for investigational new drug (IND) for intralesional recombinant human epidermal growth factor (rhEGF) produced by the Cuban regime.

This medication is intended for the treatment of complex ulcers, one of the most serious complications of diabetes, explained the Cuban pharmaceutical industry group BioCubaFarma, in a statement. .

The FDA reviewed the application and granted DTC authorization to continue its Phase 3 clinical investigation, marking a significant step toward initiating the trial, the company said.

According to the Cuban regime, Heberprot-P – produced by the Center for Genetic Engineering and Biotechnology (CIGB) – is internationally recognized and has pharmacovigilance studies for 16 years.

"Since its marketing authorization in 2006, it is estimated that more than 400,000 patients worldwide have been treated with Heberprot-P for diabetic foot ulcers (DFU)," the statement says.

The statement published by BioCubaFarma cites that Dr. David Armstrong, a prominent pediatric surgeon at the University of Southern California and expert in diabetic foot ulcers, highlighted the urgent need for innovative therapies to stop the progression of ulcerations in diabetic patients.

The Phase 3 trial in the United States will evaluate the effectiveness of Heberprot-P in patients with DFU and represents an exciting opportunity to improve the treatment of this condition, he stressed.

In 2017 the medicine reached the european market, to Russia and to Latin American countries.