Elanco’s Elura™ (capromorelin oral solution) Gains U.S. Approval
October 28 2020 - 7:00AM
Business Wire
FDA issues approval for new prescription medication to manage
weight loss in cats with chronic kidney disease (CKD)
With the U.S. Food and Drug Administration (FDA) approval of
Elura™ (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:
- 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.
- Elanco Animal Health. Data on file.
- 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)
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Media Contact: Keri S. McGrath +1.317.370.8394
mcgrath_happeks@elanco.com Investor Contact: Tiffany Kanaga
+1.302.897.0668 kanaga_tiffany@elanco.com
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