Approval for commercialization of Heberprot-P® in Mexico

Havana, Cuba, May 4, 2018 – Heberprot-P® has been approved for commercialization in México. The Center for Genetic Engineering and Biotechnology (CIGB) is excited to announce regulatory approval of this innovative medicine indicated for advanced diabetic foot ulcer (DFU), which is expected to save thousands of people from lower limb amputation. The official approval date of Heberprot-P® was April 30th, 2018. Heberprot-P® stimulates granulation, accelerates DFU re-epithelization, and reduces healing time, surgical debridement, amputation risk, and recurrences. The intralesional infiltration of Heberprot-P® may be applied in combination with Good Wound Care (GWC), revascularization, and antibiotics. This medicine is an effective solution for an unmet medical need, a first in class product, unique worldwide, for DFU treatment. It is the only therapeutic choice available for advanced and complex DFU, reluctant to healing (grades 3, 4, and 5, according to Wagner’s classification).

Clinical experience derived from the intervention with Heberprot-P® in daily medical practice in Cuba was analyzed in 2013 in a study that reviewed the evolution of more than 2 000 patients as well as the pharmacovigilance of 1 788 patients, showing a 75% probability of granulation response, 61% healing rate, 71% amputation risk reduction, Bayes' favorable factor (5.40), and complete granulation in 76% of ulcers in 5 weeks (Adv. Pharmacoepidem. 2013, 2 (2): 1000128; BMC Pharm. & Toxicol, 2013, 14: 44). The International Working Group of Diabetic Foot (IWGDF) evaluated results of the clinical trial performed with Heberprot-P® in Cuba and reported in 2009 as promising, highlighting the results obtained in only 2 weeks of treatment (Diabetes Metab Res Rev 2012; 28 (Suppl 1): 119-141).

In a later systematic review, clinical trials comparing the use of growth factors with GWC (Cochrane Database of Systematic Reviews 2015, Issue 10, Art. No. CD008548), the IWGDF’s evaluation was reported on all major issues and requirements of Heberprot-P® clinical trials in Cuba. Similar criteria were expressed by the IWGDF in the guidelines on DFU healing (IWGDF Guidance, 2015: 10). A fourth study reported similar observations on the intralesional EGF infiltration method: "... a highly significant difference between groups in the prevalence of granulation tissue after just 2 weeks" (Diabetes Metab Res Rev 2016; 32 (Suppl 1): 154- 168).

Results of clinical studies performed in Cuba, Russia, Turkey, Vietnam, Argentina, Mexico, and Ukraine were enough to demonstrate safety and efficacy profile of Heberprot-P®. This medicine has been used in more than 290 000 patients with diabetic foot ulcer (DFU) in Russia, Belarus, Georgia, Ukraine, Turkey, Algeria, China, Panama, Argentina, Cuba, Dominican Republic, Venezuela, Ecuador, Libya, Uruguay, Paraguay, Colombia, Guatemala, Philippines, Vietnam, Nicaragua, Saudi Arabia, Indonesia, Seychelles, Saint Lucia, Saint Vicente, Sri Lanka, Jordan, and Kuwait.

A national survey of health and nutrition in Mexico reported that prevalence of diabetes is 9.4% of total population, which sums up more than 11 million people, 9.1% of adult diabetic suffers DFU, and amputation is indicated to 5.5% of adult diabetics (National Survey of Health and Nutrition, INEGI 2016). According to recent reports, lower limb amputation is the unique alternative for 45% of diabetics with advanced DFU in Mexico (Diabet. Foot. Ankle. 2017 Sep 6, 8 (1): 1367210). In a previous study, similar results were reported: 42% patients with advanced DFU required major amputation (Wound Repair & Regen. 24 (5): 923-927).
Written by Jose A. Buxado, MSc., Assistant Researcher, CIGB.

The Center for Genetic Engineering and Biotechnology of Havana is an institution devoted to research, development, manufacturing, and commercialization of products and technology derived from life science.

Alyane Vazquez González, BA., Communication & Media, e-mail: alyane.vazquez@cigb.edu.cu. Ave 31 e/ 158 y 190, Playa, P.O. Box 6162, Habana 10600, Cuba.

This release was published on openPR.