Elanco Receives FDA Approval for Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), the Broadest(i) Canine Oral Parasiticide Protection in a Single Monthly Dose

• Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is the first and only canine oral parasiticide to protect against six parasites, including fleas, ticks, heartworms, roundworms, hookwormsⁱⁱ and three different species of tapeworm that other brands skip creating a gap in coverageⁱⁱⁱ
• Warming temperatures and changing consumer habits have increased parasite pressure and spread across geographies, bringing with them increased public health risk.
• Experts recommend monthly treatment for zoonotic parasites^iv, like Echinococcus granulosus, a type of tapeworm.
• Credelio Quattro launch expected in first quarter of 2025

GREENFIELD, Ind., Oct. 7, 2024 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE:ELAN) today announced the U.S. Food and Drug Administration (FDA) has approved Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), becoming the broadest approved canine oral parasiticide with its protection against six types of parasites—fleas, ticks, heartworms, and the three risky intestinal parasites—roundworms, hookwormsⁱⁱ and tapeworms. Credelio Quattro is a single, monthly chewable tablet for dogs eight weeks of age or older.

"Today is another milestone in Elanco's historic era of innovation, with the third of three approvals for blockbuster potential products in the U.S. this year. More importantly, we're bringing veterinarians and pet owners the broadest parasite protection by covering six types of parasites in a monthly chewable tablet," said Jeff Simmons, President and CEO, Elanco Animal Health. "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."

Credelio Quattro is the newest addition to the Credelio^® (lotilaner) franchise and the first FDA-approved parasiticide product with four active ingredients. Credelio Quattro:

• Starts to kill ticks^v and fleas in just 4 hours.
• Kills >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^vi twice as fast^vii as sarolaner in Simparica Trio^® and afoxolaner in NexGard^®viii.
• Is gentle enough for puppies as small as 3.3 pounds and as young as 8 weeks.
• Comes in a tasty beef-flavored, easy-to-administer chewable.
• 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," said Dr. David Gosche, veterinarian and U.S. Pet Health Medical Director at Elanco. "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."

Hear more from Dr. Elise Kelly, Elanco veterinarian, who found tapeworm in her backyard.  https://elanco.wistia.com/medias/zdwym2swei

Credelio Quattro joins Elanco's broad portfolio of parasiticides, including Seresto^® and the Advantage^® family, to provide veterinarians and pet owners with an innovative new solution while also offering a wide range of products at a variety of price points where consumers choose to shop. Elanco expects Credelio Quattro to launch in the first quarter of 2025. Learn more about Credelio Quattro at CredelioQuattroVet.com.

ABOUT ELANCO

Elanco Animal Health Incorporated (NYSE:ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco,we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.

Indications

Credelio Quattro is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus) infections. Credelio Quattro kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater.

Important Safety Information

Lotilaner, an ingredient in Credelio Quattro, belongs to the isoxazoline class and has been associated with neurologic adverse reactions like tremors, ataxia, and seizures even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Dogs should be tested for existing heartworm infections before Credelio Quattro administration as it is not effective against adult D. immitis. The safe use in breeding, pregnant, or lactating dogs has not been evaluated. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. For full prescribing information see Credelio package insert.

NexGard is a registered trademark of Boehringer Ingelheim Animal Health USA Inc. Simparica TRIO is a registered trademark of Zoetis Services LLC.

Credelio Quattro, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Other company and product names are trademarks of their respective owners. © 2024 Elanco or its affiliates.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements concerning Credelio Quattro as product for canine parasite protection, the timeline for launch, commercial uptake, as well as future studies, publications and other milestones related to Credelio Quattro, and reflects Elanco's current beliefs and expectations. However, as with any animal health pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that future studies will receive regulatory approval, or that Elanco will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Elanco's expectations, see Elanco's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Elanco undertakes no duty to update forward-looking statements to reflect events after the date of this release.

ⁱ Based on label comparison of number of parasite types covered.

ⁱⁱ Uncinaria stenocephala

ⁱⁱⁱ NexGard® Plus package insert. Duluth, GA: Boehringer Ingelheim Group; 2023; Simparica Trio® package insert. Kalamazoo, MI: Zoetis Inc.; 2022; Credelio Quattro package insert. Greenfield, IN: Elanco Animal Health; 2024.

^iv CAPC CAPC Echinococcus spp 2022 (v2.0). Available at: https://capcvet. org/guidelines/echinococcus-spp/. Accessed Jul 19, 2023.

^v Ixodes ricinus

^vi Amblyomma americanum (lone star tick)

^vii  Based on the time to statistical significance vs control in a single study on Day 21 and Day 28 for reinfestations. The study compared Credelio™ (lotilaner)—not Credelio Quattro™, which contains lotilaner as well as moxidectin, praziquantel, and pyrantel—to the active ingredients in Simparica Trio™ (sarolaner, moxidectin, and pyrantel) and NexGard™ (afoxolaner). 

^viii Reif KE, Kollasch TM, Neilson JC, Herrin BH, Ryan WG, Bell MC, Beltz MS, Dryden MW, Jesudoss Chelladurai JRJ, Miller KR, Sutherland CJ. Comparative speed of kill provided by lotilaner (Credelio™), sarolaner (Simparica Trio™), and afoxolaner (NexGard™) to control Amblyomma americanum infestations on dogs. Parasite Vectors. 2024 Jul 20;17(1):313.

Investor Contact: Katy Grissom (317) 273-9284 [email protected]

Media Contact: Season Solorio (765) 316-0233 [email protected]   

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SOURCE Elanco Animal Health