Monoclonal antibody therapies for veterinary use

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.

To access the guidance, see EMA.

Posted by Dr. Tim Sandle