Havana, Mar 19 – Heberprot-P, a safe and effective Cuban medicine for treating patients with complex diabetic foot ulcers, has achieved official registration in 20 countries, said Luis Herrera, director of the Center for Genetic Engineering and Biotechnology (CIGB).
Among the nations where the medicine passed the necessary controls are Cuba, Venezuela, Ecuador, Argentina, and Ukraine, the expert told Prensa Latina.
Russia, a country with a high regulatory standard belonging to the BRICS – a group that includes Brazil, Russia, India, China and South Africa – recently joined the group of countries approving the medicine, he said.
To do this, Russian authorities carried out an inspection of the Cuban production facilities, to assess compliance with the rigorous manufacturing practices for Heberprot-P, Herrera stated. They also rigorously assessed the scientific file for the product, developed at the CIGB and currently considered the only alternative to prevent amputation of limbs in people with irreversible diabetic lesions.
Doctor Herrera stated that Russia carried out a phase-3 trial with satisfactory results, where the compound was approved, and a pharmacoeconomic study showing the cost-benefits reached with the use of Heberprot-P.
More than 28,000 diabetic patients with ulcers have been treated in Cuba, reducing the relative risk of amputation by nearly 78 percent, a truly unique result, he noted.
The expert also reported that the preparations for the 3rd International Congress “Controlling diabetes and its most severe implications,” to be run on December 10-12, 2014, have already begun in Cuba.
Source: Prensa Latina