Zoetis Announces FDA Approval of Simparica® (sarolaner) Chewables Label Extension for the Prevention of Borrelia burgdorferi Infections in Dogs

Simparica proven to block the pathogen that causes Lyme disease by killing deer ticks

PARSIPPANY, N.J. – May 26, 2021 – Zoetis today 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% 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% increase in Borrelia burgdorferi positive dogs in under 10 years and over 400,000 dogs testing positive last year. iA 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.ii 

“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.”  

About Simparica 
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.iii  Simparica starts killing ticks within 8 hours and fleas within 3 hours and is the only single ingredient product labeled for 5 species of ticks, including unique protection against the Gulf Coast tick.iv  In two different studies, Simparica was 100% effective in preventing infections that cause Lyme disease by killing deer ticks.

Important Safety Information 
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. See full Prescribing Information.

To learn more about Simparica, visit simparica.com.

About Lyme Disease 
Lyme disease is caused by a bacterial infection transmitted via the Ixodes scapularis ticks, commonly known as the deer or blacklegged tick. It is one of the most common tick-borne illnesses transmitted to dogs. A study showed that 1 in 7 deer ticks removed from pets in the northern United States were infected with the bacteria that causes Lyme disease.  Current data also supports the longstanding interpretation that Lyme disease transmission risk remains high in the northern and mid-Atlantic states and may be increasing in the upper South.v  

Clinical signs of Lyme disease in dogs include lameness, enlarged lymph nodes, fever, lack of appetite and depression. In some cases, it can also lead to kidney failure. It is possible for a dog to be subclinically infected with the disease without showing any clinical signs.

About Zoetis 
As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After nearly 70 years innovating ways to predict, prevent, detect, and treat animal illness, Zoetis continues to stand by those raising and caring for animals worldwide - from livestock farmers to veterinarians and pet owners. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics, and technologies make a difference in over 100 countries. In 2020, Zoetis generated revenue of $6.7 billion with ~11,300 employees. For more information, visit www.zoetis.com.

For Further information please contact: 
Media Contacts: 
Colleen White 
973-822-7203 
colleen.white@zoetis.com

Shannon Frieser 
312-228-6991 
shannon.frieser@ketchum.com 

References: 
iCAPC: Parasite Prevalence Maps – Canine Lyme Disease USA 2020. 
iiVeterinary Practice News. Study shows increase of Lyme disease in dogs. https://www.veterinarypracticenews.com/study-shows-increase-of-lyme-disease-in-dogs/. Accessed May 14, 2021. 
iii1. Six RH, Everett WR, Young DR, et al. Efficacy of a novel oral formulation of sarolaner (Simparica™) against five common tick species infesting dogs in the United States. Vet Parasitol. 2016;222:28-32. 2. Six RH, Liebenberg J, Honsberger NA, Mahabir SP. Comparative speed of kill of sarolaner (Simparica™) and afoxolaner (NexGard®) against induced infestations of Ctenocephalides felis on dogs. Parasit Vectors. 2016;9:90. 
ivSix RH, Geurden T, Carter L, et al. Evaluation of the speed of kill of sarolaner (Simparica™) against induced infestations of three species of ticks (Amblyomma maculatum, Ixodes scapularis, Ixodes ricinus) on dogs. Vet Parasitol. 2016;222:37-42. 
vParna Ghosh, Meriam N. Saleh, Kellee D. Sundstrom, Michelle Ientile, and Susan E. Little.Vector-Borne and Zoonotic Diseases. Jan 2021.11-19. http://doi.org/10.1089/vbz.2020.2637 

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