FDA approves oral drug for broad canine protection against parasites

Photo: andriano_cz/Adobe Stock

The FDA has approved lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets (Credelio Quattro; Elanco Animal Health) for canine protection against 6 types of parasites, according to the company. The treatment provides a broad oral parasiticide for dogs with protection against fleas, ticks, heartworms, roundworms, hookworms, and tapeworms.¹

“Today is another milestone in Elanco's historic era of innovation, with the third of 3 approvals for blockbuster potential products in the US this year. More importantly, we're bringing veterinarians and pet owners the broadest parasite protection by covering 6 types of parasites in a monthly chewable tablet," Jeff Simmons, president and CEO of Elanco Animal Health, said in an organizational release.¹ "As pets have become such an integral part of the family, we're pleased to offer veterinarians and pet owners a first-of-its-kind solution that protects against some of the most dangerous parasites that can spread disease to both pets and people.”

The combination chewable tablet is indicated for administration once a month and is suitable for canines 8 weeks of age or older. It is the latest member of the Credelio (lotilaner) line and is the first FDA-approved parasiticide featuring 4 active ingredients. According to Elanco, the newly approved preventive¹:

• Starts to kill ticks (Ixodes ricinus) and fleas in 4 hours
• Kills more than 99% of fleas within 8 hours of administration and 100% in the first day, and remains effective for an entire month
• Provided 100% protection from heartworm disease from the first monthly dose in laboratory studies
• Contains lotilaner that kills ticks (Amblyomma americanum; lone star tick) twice as fast as sarolaner and afoxolaner
• Is gentle enough for puppies as small as 3.3 lbs and as young as 8 weeks
• Comes in a beef-flavored chewable tablet
• Provides coverage against internal parasites with zoonotic potential, meaning parasites that have the potential to infect people as well as pets, including echinococcus tapeworm

"Zoonotic disease is more common than many might think. One of our own Elanco veterinarians recently found echinococcus tapeworm lurking in her back yard," David Gosche, DVM, US pet health medical director at Elanco, said in the release.¹ "Zoonotic disease affects millions of people and animals worldwide each year. Our pets can easily serve as the 'bridge hosts,' bringing these parasites into our homes when they cuddle with us on couches or in our beds—making it very easy to go from 'ick' to 'sick.' That's why we recommend year-round treatment with the broad-spectrum parasite protection in Credelio Quattro."

According to the company, rising temperatures and shifting consumer behaviors have heightened parasite pressure and their spread across different regions, leading to greater public health risks.¹

Credelio Quattro is expected to launch in the first quarter of 2025. In addition to the regulatory process, Elanco also plans to complete a manufacturing scale-up to facilitate the launch of its product.²

References

1. Elanco receives FDA approval for Credelio Quattro (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), the Broadest (i) canine oral parasitice protection in a single monthly dose. News release. Elanco Animal Health. October 7, 2024. Accessed October 7, 2024. https://prnmedia.prnewswire.com/news-releases/elanco-receives-fda-approval-for-credelio-quattro-lotilaner-moxidectin-praziquantel-and-pyrantel-chewable-tablets-the-broadesti-canine-oral-parasiticide-protection-in-a-single-monthly-dose-302269212.html
2. McCafferty C. Credelio Quattro advances to final FDA administrative review. dvm360. August 20, 2024. Accessed October 7, 2024. https://www.dvm360.com/view/credelio-quattro-advances-to-final-fda-administrative-review