First guidance on monoclonal antibodies for use in animals

News 11/12/2017

Guidance supports development of novel veterinary therapies

The European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has approved the first ever guidance at European Union (EU) level for monoclonal antibody therapies for veterinary use. The guidance was prepared by the CVMP's Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) in the form of a question-and-answer document.

The guidance relates to particularities of monoclonal antibodies for veterinary use, quality control for potential contaminants, stability testing, reproductive safety studies and data to address potential for indirect adverse effects.

Monoclonal antibodies are immune proteins that recognise and bind to a specific target protein, and have not been used in veterinary medicines until recently. In human medicine, these therapies have been authorised for many years for use against cancer and diseases affecting the immune system, such as rheumatoid arthritis. Therapies that are new to veterinary medicine face particular challenges due to a lack of regulatory guidance. Despite these challenges, the first veterinary medicine containing a monoclonal antibody was recommended for approval by the CVMP in February 2017.

Veterinary novel therapies refer to therapies that are either genuinely new, or new only to the veterinary domain, although well known in the context of human medicines.

Interest and research activities into veterinary novel therapies have increased over the last few years. The CVMP identified monoclonal antibodies as one of the priority areas that would benefit from specific guidance, following a review of relevant scientific evidence, such as published literature, available guidance on such medicines for human use, experience gained by the CVMP through scientific advice and public consultations.

ADVENT brings together broad knowledge and expertise on the scientific aspects of veterinary medicines and their regulation. The group makes use of additional expertise from across the European network. It was set up by the CVMP to prepare general guidance on the requirements for authorisation of novel veterinary medicines. In this context, the group also prepares guidance on other types of novel therapies. For example, guidance on three different aspects of veterinary stem cell therapies was published earlier this year.

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