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Biopharmaceuticals FDA

 News Release - January 22, 2018

Elanco Animal Health Announces U.S. Food and Drug Administration (FDA) Approval of Credelio(R) (lotilaner) to Treat and Protect Against Ticks and Fleas

New monthly oral tick and flea treatment offers easy dosing, efficacy in as little as four hours, all month long

GREENFIELD, Ind., Jan. 22, 2018 -- (Healthcare Sales & Marketing Network) -- Today, Elanco Animal Health, a division of Eli Lilly and Company (NYSE: LLY), announced the approval of Credelio® (lotilaner). Credelio is a new monthly oral tick and flea treatment that is easy on dogs, but tough on ticks and fleas. This new tick and flea option for dogs contains the patented active ingredient lotilaner, which targets the nervous system receptors of ticks and fleas, not dogs.1

Credelio is a small, tasty2 chewable tablet approved for puppies and dogs eight weeks of age and older and 4.4 pounds and greater. Credelio protects against ticks of common concern across the U.S.: lone star tick (Amblyomma americanum), American dog tick (Dermacentor variabilis), black-legged tick (Ixodes scapularis) and brown dog tick (Rhipicephalus sanguineus), as well as fleas (Ctenocephalides felis).

"When choosing pet medications, veterinarians and pet owners are most concerned with safety for the pet as well as efficacy of the product. Lotilaner, the active ingredient in Credelio, was selected from hundreds of candidate molecules with this in mind," said Tony Rumschlag, DVM, Director, Regional Consulting, Elanco Animal Health. "This new tasty chewable is fast-acting and effective against ticks and fleas, while being easy on dogs and puppies. Credelio rounds out the Elanco portfolio of companion animal parasiticides to allow a very broad set of options to best meet the needs of pet owners and their pets."

Easy on Dogs

In a field study, 100 percent of Credelio tablets were administered successfully and dogs accepted 94 percent of them when offered by hand, in an empty bowl, or with food.2 Credelio is also well accepted by a broad range of dog breeds, including toy dogs such as Chihuahuas and Yorkshire terriers.2-5 Further, Credelio offers the reassurance of a product that is suitable for puppies as young as eight weeks of age.

Tough on Ticks and Fleas

Credelio's active ingredient—lotilaner—circulates in the dog's blood stream, targeting the receptors of ticks and fleas when they bite the dog. In clinical studies, Credelio killed 100 percent of fleas within 12 hours for the entire month.6 Credelio starts to kill ticks and fleas in just 4 hours6,7. This fast initial onset of action provides rapid relief from existing ticks. Credelio's sustained speed-of-kill throughout the dosing period provides protection from newly-acquired ticks. Credelio works fast because it is absorbed rapidly and achieves peak plasma levels quickly. When given with food, Credelio reaches peak blood levels within 2 hours of dosing.8

As a global leader in the animal health industry, Elanco supports veterinarians with a wide range of parasiticide solutions. "The introduction of Credelio expands our portfolio even further with a once-a-month, oral tick and flea product that supports Elanco's commitment to helping pets live longer, healthier, higher-quality lives," said Cathy Martin, Director of U.S. Companion Animal Marketing.

Credelio will be available in four tablet strengths for dogs and is approved for puppies and dogs from eight weeks of age and older and 4.4 pounds and greater.

Visit Credelio.com for more information.

Indications Credelio kills adult fleas and is indicated for the treatment 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 4.4 pounds or greater.

Important Safety Information

The safe use of Credelio in breeding, pregnant, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. The most frequently reported adverse reactions are weight loss, elevated blood urea nitrogen, excessive urination, and diarrhea. See package insert for full safety information.

About Elanco

Elanco provides comprehensive products and knowledge services to improve animal health and food-animal production in more than 70 countries around the world. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 6,500 employees worldwide. Together with our customers, we are committed to raising awareness about global food security, and celebrating and supporting the human-animal bond. Founded in 1954, Elanco is a division of Eli Lilly and Company. Our worldwide headquarters and research facilities are located in Greenfield, Indiana. Visit us at Elanco.com and EnoughMovement.com.

References 1Rufener, L. et al. 2017. "The novel isoxazoline ectoparasiticide lotilaner (Credelio®): a noncompetitive antagonist specific to invertebrates ?-aminobutyric acid-gated chloride channels (GABACls)." Parasites & Vectors. 10:530.

2Karadzovska, D. et al. 2017. "A randomized, controlled field study to assess the efficacy and safety of lotilaner flavored chewable tablets (Credelio®) in eliminating fleas in client-owned dogs in the USA." Parasites & Vectors. 10:528.

3Cavalleri, D. et al. 2017. "A randomized, blinded, controlled field study to assess the efficacy and safety of lotilaner tablets (Credelio®) in controlling fleas in client-owned dogs in European countries." Parasites & Vectors. 10:526.

4Cavalleri, D. et al. 2017. "A randomized, controlled study to assess the efficacy and safety of lotilaner (Credelio®) in controlling ticks in client-owned dogs in Europe." Parasites & Vectors. 10:531.

5Elanco Animal Health. Data on File.

6Cavalleri, D. et al. 2017. "Assessment of the speed of flea kill of lotilaner (Credelio®) throughout the month following oral administration to dogs." Parasites & Vectors. 10:529. 7Murphy, M. et al. 2017. "Laboratory evaluation of the speed of kill of lotilaner (Credelio®) against Ixodes ricinus ticks on dogs." Parasites and Vectors. 10:541.

8Toutain C. et al. 2017. "The intravenous and oral pharmacokinetics of lotilaner in dogs." Parasites & Vectors. 10:522.

Credelio, Elanco, and the diagonal bar logo are trademarks of Eli Lilly and Company or its affiliates.


Source: Elanco Animal Health

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