Target product profiles for snakebite treatments

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Target Product Profiles (TPPs) provide information about the characteristics of products such as medicines, diagnostic devices, and other commodities, usually aimed at the detection and treatment of particular diseases.

They provide guidance on a range of important features of products; their target uses and populations, safety, efficacy, effectiveness, and other characteristics. Used effectively, they can help researchers, biopharmaceutical manufacturers, regulators, procurement agencies and clinicians to match products to specific use-cases in a way that reduces development risks, helps inform and streamline regulatory approval processes, and ensure that they best meet the needs of the market and the patients who stand to benefit from them.

Unfortunately, most of the treatments for snakebite envenoming that are currently marketed in different parts of the world, were designed, and developed without the benefit of TPPs to ensure that they meet at least minimal requirements to match the needs of the markets where they are used.

WHO has responded proactively to the need to make information on the preferred optimal and minimal characteristics of such products available to better inform relevant stakeholders and improve the treatment of snakebite envenoming. With the assistance of the Technical and Scientific Advisory Group (TSAG) on TPPs for antivenoms and other snakebite envenoming treatments, WHO is developing and publishing TPPs for a range of applications, including:

1. Conventional animal plasma-derived antivenoms, such as those made from the plasma of horses, camels, or sheep that have been hyperimmunized with snake venoms.
2. Engineered antibody therapeutics such as monoclonal, recombinant, or humanized antibody-based drugs.
3. Small molecule inhibitor-based therapeutics that abrogate the effects of specific venom components.

   These TPPs are important because high-quality conventional antivenoms are the most effective treatment for treatment. Newer products have the potential to replace conventional antivenoms, to be administered adjunctively with them and/or as pre-hospital “first aid” interventions.

In some areas of the world children make up 35-50% of all snakebite cases. Their small size and unique physiology make them especially vulnerable to snakebite envenoming. Improving the quality, safety and effectiveness of antivenoms is important to ensuring good outcomes for all snakebite victims, and especially children. (Credit image: David Williams)

We describe here WHO public-benefit Target Product Profiles (TPPs) for antivenoms intended to be used for treatment of snakebite envenoming in South Asia, the region of the world that harbours arguably the greatest burden of morbidity and mortality from snakebites. Four TPPs are described.

• The first is for products that are intended for widespread use throughout south Asia, for treatment of envenoming irrespective of the species of snake causing a bite. This would include products minimally targeted to treat the ‘big four’ species that dominate the landscape of snakebites in the south Asian sub-continent.
• The second is for products where the snakebite causes predominantly neurotoxic effects.
• The third is for snakebites where the effects are largely haemorrhagic or procoagulant.
• The fourth is for treatment of envenoming for a single species or genus of snake.

These TPPs are intended to provide guidance to manufacturers, regulators, procurement agencies, clinicians, and researchers, to improve antivenoms and thus treatment of snakebite envenomation.