Benzinga | Jan 5, 2022 11:24AM EST

Zoetis Announces FDA Approval of Simparica Trio New Label Indication For Prevention Of Borrelia Burgdorferi Infections In Dogs

ARSIPPANY, N.J. --January 4, 2022-- Zoetis today announced that the U.S. Food and Drug Administration (FDA) has approved a new label indication for Simparica Trio(r) (sarolaner, moxidectin, and pyrantel chewable tablets) for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks (black-legged or deer ticks). Simparica Trio is approved for dogs eight weeks of age and older weighing 2.8 pounds and greater. Simparica Trio is the first and only combination product demonstrated to prevent infections that may cause Lyme disease by killing deer or black-legged ticks.

"Tick-borne diseases are a serious threat to pets and Lyme disease, caused by Borrelia burgdorferi, is transmitted by deer ticks. It is critical to have easily accessible and effective options for preventing infections available to protect dogs from ticks so they can spend more quality time with their owners," said Jen Sheehy, DVM BCPA, Medical Lead for Parasitology at Zoetis. "This new efficacy claim provides a new tool to veterinary teams who understand that healthy pets mean happy people and who work every day to provide the best care for our dogs."

Lyme disease is one of the most common tick-borne illnesses transmitted to dogs and data shows that it is a growing threat to dogs in the United States.1 This is the first new indication for Simparica Trio since its approval in February 2020, and it is particularly significant as ticks are a threat year-round. In fact, deer ticks that can carry Lyme disease are especially active in cooler months.2 In 2020, one in 20 dogs across the United States tested positive for Lyme infection.3

"Once dogs are infected with Borrelia burgdorferi, the bacteria's unique mode of motility allows it to rapidly disseminate throughout the body. This can make the infection difficult to treat," said Dr. Richard T. Marconi, Ph.D. (Microbiology & Immunology, Virginia Commonwealth University Medical Center).i "The most important thing we can do is to prevent infection in the first place using a comprehensive strategy that includes the use of an effective tick preventative product and vaccination."

Simparica Trio delivers on Zoetis' commitment to innovation in parasiticides

The evolution of Simparica Trio's labeling is just the latest example of Zoetis' commitment to next-generation parasiticide products and solutions for veterinarians, enabling them to provide the best prevention and treatment options for pets. Simparica Trio is the first and only product to provide all-in-one protection against heartworm disease, ticks* and fleas, roundworms and hookworms** in a single monthly chewable. Now with FDA approval for the prevention of Borrelia burgdorferi infections by killing deer ticks, Simparica Trio can deliver the comprehensive protection that every dog deserves.

This recent label expansion also included approval for the treatment and control of immature stages (L4 and immature adult) hookworm, which helps provide a more comprehensive intestinal parasite control program. With this addition, Simparica Trio is now approved for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4 and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. Treatment and control of immature and adult roundworms and hookworms help reduce environmental contamination from worm eggs and lowers the risk of infection in dogs.