Zoetis Announces FDA Approval of Simparica Chewables Label Extension

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Press release: Zoetis

Zoetis recently announced that the U.S. Food and Drug Administration (FDA) has approved a new label indication for Simparica (sarolaner) Chewables for the prevention of Borrelia burgdorferi infections as a result of killing Ixodes scapularis ticks (deer ticks) for dogs six months of age or older. In two separate studies, Simparica prevented 100 percent of infections that cause Lyme disease, even when challenged near the end of the month.

This new indication for Simparica is particularly significant, as Companion Animal Parasite Council (CAPC) data has shown that Lyme disease is a rising threat to dogs in the United States, with a 147 percent increase in Borrelia burgdorferi positive dogs in under 10 years and over 400,000 dogs testing positive last year. A CAPC study also found that the prevalence of Ixodes scapularis ticks carrying the Borrelia burgdorferi pathogen has increased across the Northeast, as well as in states not typically considered endemic, including regions in Illinois, Iowa, North Dakota, Ohio, Michigan and Tennessee.

“Lyme disease, caused by Borrelia burgdorferi, is transmitted by deer ticks, which are expanding to new areas of the country. So, it’s important for veterinarians to be aware of the current distribution of deer ticks as well as local prevalence of Lyme disease-positive dogs,” said Chris Adolph, DVM, MS, ACVM, Senior Veterinary Specialist in Parasitology at Zoetis. “All dogs in the United States need year-round tick protection to aid in controlling the spread of tick-borne pathogens. Now that Simparica has a new label claim to block the transmission of the pathogen responsible for Lyme disease, as a direct result of killing deer ticks, veterinarians now have even greater comfort that they are protecting dogs and helping them live healthy, happy lives.”

Simparica, a member of the isoxazoline class of medications, is a monthly tick and flea chewable that provides 35 days of protection against ticks and fleas, without losing effectiveness at the end of the month. Simparica starts killing ticks within eitht hours and fleas within tree hours and is the only single ingredient product labeled for five species of ticks, including unique protection against the Gulf Coast tick. In two different studies, Simparica was 100% effective in preventing infections that cause Lyme disease by killing deer ticks.

Simparica is for use only in dogs 6 months of age and older. Simparica may cause neurologic signs such as tremors, unsteadiness and/or seizures in dogs with or without a history of neurologic disorders. Simparica has not been evaluated in pregnant, breeding or lactating dogs. The most common adverse reactions in clinical trials were vomiting and diarrhea.