Veterinary drug maker Zoetis Inc. is celebrating achievements on both sides of the Atlantic after winning European approval of a new flea and tick preventive and USDA endorsement of a canine flu vaccine.
The Florham Park, N.J., company also announced the release of an equine leptospirosis vaccine.
The flea and tick drug, Simparica (sarolaner), is a chewable tablet given monthly to dogs as young as 8 weeks. It also is indicated for the treatment of sarcoptic mange, a contagious skin disease.
Zoetis described the active ingredient, sarolaner, as a new ectoparasiticide in the isoxazoline class.
Simparica, approved by the European Commission, was tested on more than 800 dogs in seven countries, Zoetis reported. The drug was found “to provide efficacy for at least five weeks against ticks and fleas” and “demonstrated a rapid onset of action, killing fleas before they have a chance to lay eggs,” the company added.
Simparica kills four common European ticks—Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus—as well as the fleas Ctenocephalides felis and Ctenocephalides canis.
The tablets are expected to be released in early 2016 in dosages of 5, 10, 20, 40 and 80 milligrams.
U.S. veterinarians could see Simparica on clinic shelves in the months ahead.
“We anticipate a decision from the U.S. Food and Drug Administration in the first half of 2016,” Zoetis spokeswoman Elinore White said.
The company’s new flu fighter, Canine Influenza Vaccine, H3N2, Killed Virus, earned a conditional license from the U.S. Department of Agriculture and is the first commercially licensed vaccine of its kind.
H3N2 made headlines last spring when more than 1,000 dogs in Chicago contracted the virus, which has since spread to about two dozen other states.
“Following the initial outbreak of CIV H3N2 in Chicago, Zoetis researchers immediately prioritized development of a vaccine,” said Shelley Stanford, DVM, MS, MBA, the group director of Companion Animal Veterinary Professional Services.
“We are very proud that we had the capability to address the pressing need for a vaccine to help control the spread of CIV H3N2 in just seven months,” Dr. Stanford said.
The vaccine should be given in two doses three weeks apart, and annual revaccination is recommended, Zoetis stated.
In other news, the company this month introduced Lepto EQ Innovator, a vaccine formulated to prevent the bacterial infection leptospirosis in horses. The vaccine is indicated for the prevention of leptospirosis caused by the organism Leptospira interrogans serovar pomona (L. Pomona).
It may be administered to foals at least 3 months old and to healthy pregnant mares in the second trimester, Zoetis noted.