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1 April 2021

Elanco Animal Health Introduces Newest Innovation for Cats, Elura™ (capromorelin oral solution), to U.S. Veterinarians

Posted by: Keri McGrath

FDA-approved Elura is a first-in-class solution to help manage weight loss in cats, providing innovation in patient care that veterinarians are looking for

Greenfield, Ind. (March 31, 2021) – Veterinarians in the U.S. now have a new treatment option to help manage weight loss in cats with chronic kidney disease (CKD) as Elanco Animal Health Incorporated (NYSE: ELAN) makes Elura available.

“Elura is an exciting new treatment option for cats with chronic kidney disease (CKD), as it mitigates weight loss associated with this progressive condition,” said Dr. Audrey Cook, Professor, Texas A&M University. “Elura is an oral, flavored solution with a low dosing volume. It should be introduced at the time of diagnosis and can be used as long-term treatment to help pet owners support their cats throughout the course of this disease.”

Elura is the first ghrelin receptor agonist to be approved for use in cats providing a novel mechanism of action to address weight loss in cats with CKD. Based on the mechanism of action, weight gain in cats taking Elura is thought to be due to increased food intake and metabolic changes.

CKD causes progressive weight loss due to a variety of factors including decreased appetite, malabsorption, and increased energy requirements. This weight loss – which translates to loss of energy, immune function and muscle deterioration – has shown to negatively impact survival.[1]

Studies show Elura helps cats with CKD gain weight. In the pivotal field study, use of Elura in cats with CKD led to weight gain in more than 80% of treated cats over the 56-day study period, compared to approximately 40% of controls. Significant weight gain was recognized as early as day 15. Elura was tested for 6 months in healthy cats in a safety study, supporting long-term use of Elura.[2]

 CKD can be seen in cats of any age but is most commonly seen in middle-to-old-aged cats (those over 7 years), and it becomes increasingly common with age. As cats are living longer lives due to better overall care, chronic diseases associated with aging such as CKD are a growing concern for veterinarians. It is estimated that greater than 30-40% of cats over 10 years of age will have some degree of CKD present.3

“Because CKD is a long-term, progressive disease in cats that poses significant quality of life challenges, we are excited to bring Elura to U.S. veterinarians,” said Tony Rumschlag, DVM, director of consulting veterinarians at Elanco.

[1] Freeman LM, Lachaud MP, Matthews S, et al. Evaluation of weight loss over time in cats with chronic kidney disease. Journal of veterinary internal medicine. 2016 Sep;30(5):1661-6.

[2] Elura Freedom of Information Summary.  NADA 141-536. 2020

­3 Sparkes AH, Caney S, Chalhoub S, et al. ISFM Guidelines on the Diagnosis and Management of Feline Chronic Kidney Disease. J Feline Med Surg. 2016 Mar;18(3):219-39

Approved by the U.S. Food and Drug Administration (FDA) in October 2020, Elura joins Elanco’s growing therapeutic portfolio, which includes solutions in the areas of pain management, internal medicine, oncology and dermatology.

For more information about Elura and Elanco’s cat health portfolio, please visit:

https://www.elanco.us/products-services/cats


INDICATION

For management of weight loss in cats with chronic kidney disease.


IMPORTANT SAFETY INFORMATION

For oral use in cats only. Do not use in cats that have a hypersensitivity to capromorelin, or in cats with hypersomatotropism (acromegaly). Elura may increase serum glucose for several hours after dosing; use in cats with current or historical diabetes mellitus has not been evaluated and may not be appropriate. Use with caution in cats that may have cardiac disease, severe dehydration, or hepatic dysfunction. Elura has not been evaluated in cats younger than 5 months of age, or in breeding, pregnant or lactating cats.The most common adverse reactions included vomiting, hypersalivation, inappetence, behavior change and lethargy. Click http://www.elancolabels.com/us/elura for full prescribing information or call 1-888-545-5973.


ABOUT ELANCO ANIMAL HEALTH
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™ ESG/Sustainability framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.


Forward Looking Statement

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Elura and reflects Elanco’s current belief. Forward-looking statements are based on our current expectations and assumptions regarding our business and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. For further discussion of these and other risks and uncertainties, see Elanco’s most recent 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.

Elura, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2021 Elanco or its affiliates. PM-US-21-1011

Media Contact:

Keri McGrath Happe

+1 317-370-8394

mcgrath_happeks@elanco.com

Investor Contact

Tiffany Kanaga

+1.302.897.0668

Tiffany.Kanaga@elancoah.com


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Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2021 Elanco.
PM-US-21-1011