MSD Animal Health Receives Positive EU CVMP Opinion to Update EXZOLT® SPC for Improving Animal Welfare

First Veterinary Product Centrally Registered in EU to Include Animal Welfare Improvement in its SPC

European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) issued a positive opinion for an update to the Summary of Product Characteristics (SPC) for its veterinary medicinal product EXZOLT® (fluralaner) solution for use in drinking water for chickens, MSD Animal Health has announced.

The update to the SPC is based on results from a multi-site EU field study in commercial egg production farms that demonstrated the elimination of poultry red mite (Dermanyssus gallinae) from infested chickens following treatment with EXZOLT was associated with statistically significant improvement in behavioral parameters indicative of animal welfare.

These parameters include reduction of night-time activity, head scratching, head shaking and preening at night and during the daytime, as well as a reduction of blood corticosterone concentration.i EXZOLT is the first veterinary product centrally registered in the EU to include animal welfare improvement in its SPC.

‘Welfare threat’

“Red mite infestations are a major animal welfare threat to chickens and a top-five cause of economic loss in European layer and breeder operations,” said Rik Koopman, director of scientific marketing affairs, MSD Animal Health.

“Mite bites cause significant pain and skin irritation, contributing to chronic stress in infested birds characterized by feather pecking, head scratching and decreased weight gain, as well as immunosuppression.

“Poultry red mites may also act as vectors for chicken pathogens and contribute to disease spread within and between flocks, as well as between chickens and humans. MSD Animal Health is proud to advance EXZOLT as a part of our commitment to The Science of Healthier Animals®, to further decrease the threat of poultry red mite across European farms in addition to preserving the health and well-being of chickens and the people who care for them.”

EXZOLT was the first systemic treatment for poultry red mite infestation, and it is the only poultry product centrally registered in the EU to include data demonstrating improvement in animal welfare within its SPC. EXZOLT is administered via drinking water and begins working against mites within four hours after mites start to feed on treated chickens, resulting in virtual elimination of infestation within production houses of any size or type, including free-range.

“Over 8 million hens have been treated with EXZOLT on the island of Ireland since the product was launched in in 2017,” said Michael McCreesh, Poultry Business Unit Director for MSD Animal Health Ireland. “As a result of which, farmers and vets alike have been able to see first-hand that effective red mite treatment results in happier, healthier hens.”