The World Health Organization (WHO) has published the first in a series of WHO public-benefit target product profiles (TPPs) for snakebite treatments, in order to improve the quality of anti-venoms available in the market. This is the first-ever guidance to improve the quality of such products, reports UNB.
The TPP is a document that provides regulators, manufacturers, researchers and procurement agencies with essential information about the minimum and optimum characteristics of specific products for specific use cases, in this case, anti-venoms used for the treatment of snakebites from various sub-Saharan African snakes.
TPPs help to ensure that products are designed and manufactured to match the clinical needs of populations at risk, and are “fit-for-use” – e.g., are safe, effective and adapted to the use environment,
High-quality anti-venom provides the best available treatment for approximately 5.4 million people who are bitten by snakes every year. Safe, effective anti-venoms could prevent many of the 83,000-138,000 deaths caused by snakebites and reduce the severity of serious disabilities that impact thousands of victims more.
“Access to high quality, safe and effective anti-venom is an issue of equity and this critical work brings us one step forward in being able to make this a reality” said director of the WHO Global NTD Programme Socé Fall.
Anti-venoms have been made for some 130 years and yet, remarkably, there has been until now, no guidance on how to design and manufacture a product of high quality that meets the correct requirements for safety, effectiveness, and functional use.
Four TPPs for different types of conventional animal plasma-derived anti-venoms, the first of these is for products that are intended for widespread use throughout sub-Saharan Africa, for treatment of snakebites irrespective of the species of snake causing the bite. The second is for treatment of bites from a single species (or group) of snake(s). Products in both these categories are currently on the market.
The other two categories are for products that do not yet exist in sub-Saharan Africa, but evidence from other parts of the world suggests that if developed they may have a useful role to play. One of these new product types is for anti-venoms where the snakebite mainly causes a syndrome dominated by neurotoxic effects, while the other is intended for non-neurotoxic snakebite syndromes that involve effects on blood clotting or tissue necrosis without paralytic effects.
These TPPs, are intended to provide guidance to manufacturers, regulators, procurement agencies, clinicians and researchers and will contribute to improvements in the quality, safety and effectiveness of anti-venoms and thus better treatment of snakebites.