MSD receives positive opinion to update EXZOLT® SPC
February 23, 2021 - MSD Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA, announced that the 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.
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.
“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.