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28 October 2020

ELANCO’S ELURA (capromorelin oral solution) GAINS U.S. APPROVAL

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Post by: Keri S. McGrath

FDA issues approval for new prescription medication to manage weight loss in cats with chronic kidney disease (CKD)

Greenfield, Ind. (October 28, 2020) – With the U.S. Food and Drug Administration (FDA) approval of  EluraTM (capromorelin oral solution), a new prescription medication to manage weight loss in cats with chronic kidney disease (CKD), Elanco Animal Health (NYSE: ELAN) expands its feline offerings while addressing an unmet need in an increasingly common condition as cats age.  


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 survival1.


“With the management of any chronic disease, providing solutions that can be used long-term is critical,” said Racquel Harris Mason executive vice president and chief marketing officer of Elanco. “Elura is a once-daily oral solution and the first of its kind to specifically address weight loss in cats with CKD, providing innovation in patient care that veterinarians are looking for.”


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, the clinical effects of Elura are thought to be due to a combination of increased food intake and metabolic changes that lead to weight gain.


“When veterinarians diagnose a cat with CKD, they know the cat will lose weight and waste away over the course of the disease.  This is heartbreaking for veterinarians and for the families they care for,” said Dr. Tony Rumschlag, head of consulting veterinarians for Elanco. “It’s exciting to add a new treatment option to manage this otherwise inevitable decline.”


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 15.2  Elura was well-tolerated in this study as well as a 6-month safety study, supporting the long-term use of this product to provide the metabolic support needed in managing weight loss in cats with chronic kidney disease.3


“Elura represents an important milestone in the diversification of our portfolio, with a constant flow of internal and external innovation creating a durable pipeline to service our varied customer base of pet owners, veterinarians and farmers,” said Aaron Schacht, executive vice president of Research and Development for Elanco. “This is our innovation strategy at work.”  


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 Elanco’s cat health portfolio, 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.  For full prescribing information, call 1-888-545-5973.


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™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com


References:

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.) Elanco Animal Health.  Data on file.

3.) Elura Freedom of Information Summary.  NADA 141-536. 2020.


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.


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

© 2020 Elanco or its affiliates. PM-US-20-2353 (2)

Media Contact:

Keri McGrath Happe

+1 317-370-8394

mcgrath_happeks@elanco.com

Investors Contact:

Tiffany Kanaga

+1.302.897.0668

kanaga_tiffany@elanco.com

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Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2020 Elanco.
PM-US-20-2353 (2)