Today, Elanco Animal Health Incorporated (NYSE: ELAN) announced
that the first shipments of Varenzin™-CA1 (molidustat oral
suspension), conditionally approved by U.S. Food and Drug
Administration (FDA) as the first and only treatment to control
non-regenerative anemia in cats with chronic kidney disease (CKD),
are shipping to veterinary clinics around the country. Anemia from
CKD can dramatically affect a cat’s existence, making them
lethargic, reducing their appetite, and even leading to a rapid
heart rate and difficulty breathing in severe cases. According to
the FDA, CKD-related anemia is a complication that often
contributes to death or euthanasia of affected cats due to poor
quality of life.i The challenges of current therapy to address this
devastating condition often include inconvenient and extra-label
use of a human drug.
“Varenzin-CA1 is the first drug to receive conditional approval
for use in cats, providing access to a novel medicine for our
feline companions suffering from nonregenerative anemia due to
CKD,” said the FDA Center for Veterinary Medicine, upon
conditionally approving the product. “Additionally, this is the
first drug for cats under expanded conditional approval, a pathway
to the marketplace that encourages development of innovative
treatments and increases the options for treating animals with
uncommon conditions, serious or life-threatening diseases, or
diseases without existing or adequate therapies.”
CKD-related anemia stops cats’ bone marrow from producing enough
red blood cells to replace the older or damaged red blood cells
that are naturally removed from the blood, resulting in the
inability for oxygen to be carried from the lungs throughout the
body. CKD is common among mature and senior cats, occurring in
about 15-30% of feline patients over 12 years old. Anemia is a
common finding in over half of all CKD-diagnosed cats.ii However,
prior to Varenzin-CA1, less than one-third of anemic cats received
treatment.iii This latest innovation from Elanco addresses an unmet
need for this chronic condition in mature cats and furthers
Elanco’s feline portfolio aimed at keeping cats healthy throughout
their lives, especially as they age.
“Chronic kidney disease is not curable, so veterinarians and pet
owners are focused on improving quality of life and slowing disease
progression in affected cats,” said Dr. Melinda Wood, Specialty
Consulting Veterinarian at Elanco. “Varenzin-CA1 is an innovative,
needle-free oral suspension option for cats that can be given
at-home – no in-clinic injections needed. This innovation sets a
new standard of care for cats suffering from the debilitating
effects of this disease. It represents a paradigm shift in the
early-treatment of CKD-related anemia and helps CKD cats feel more
like their feline selves.”
In a series of studies, Varenzin-CA1 was shown to have a
reasonable expectation of efficacy in managing anemia in CKD cats.
By day 28, 50% of cats given Varenzin-CA1 had increased their red
blood cell count, and by day 56, 75% of cats had increased their
red blood cell count, improving the ability to deliver necessary
oxygen and nutrients to their bodies.
As a leader in feline care, Elanco has focused on bringing
cutting edge products, like Varenzin-CA1, to market, in an effort
to address challenges for pet owners and veterinarians, while
improving the wellbeing of pets. This latest technology adds to
Elanco’s existing feline portfolio, including Elura® (capromorelin
oral solution) for cats, the only FDA-approved treatment
specifically designed for the management of weight loss in cats
with CKD. These products are helping to improve the lives of older
cats and reducing the burden of care for their owners as they
age.
“The bond with our pets only deepens over time,” says Dr. Wood.
“Unfortunately, it’s not uncommon for aging cats to be diagnosed
with conditions that steal their personalities and make it hard for
their owners to provide ongoing care. Elanco is uniquely offering
products to address these later-stage health challenges, so cat
owners no longer have to accept a sub-optimal existence for their
mature and senior pets.”
This conditional approval reinforces Elanco’s commitment to
pioneering solutions in the underserved chronic disease state and
feline market through a growing portfolio of treatment options. For
more information, visit
https://my.elanco.com/us/campaign/varenzin.
Varenzin-CA1 Indication
Varenzin-CA1 is indicated for the control of nonregenerative
anemia associated with chronic kidney disease (CKD) in cats.
Varenzin-CA1 Important Safety Information
For oral use in cats only. Keep this drug, including used
syringes, out of reach of children. Wash hands immediately after
use. In case of accidental ingestion, seek medical advice
immediately. Women who are pregnant or may become pregnant should
administer the product with caution. Varenzin-CA1 should not be
administered to cats that are pregnant, lactating or intended for
breeding or to cats with known hypersensitivity to molidustat. Use
with caution in cats with a history of seizures and in cats
predisposed to thromboembolic disease. Hematocrit (HCT) or packed
cell volume (PCV) levels should be monitored regularly as
polycythemia may result from use of Varenzin-CA1. Varenzin-CA1 has
not been evaluated in cats less than 1 year of age. The most common
adverse reactions included vomiting, increases in systolic blood
pressure and mild transient increase in serum potassium. Click here
for full prescribing information.
Elura Indication:
Elura is indicated for management of weight loss in cats with
chronic kidney disease.
Elura 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 here to see Elura product label for full
prescribing information.
ABOUT ELANCO
Elanco Animal Health (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’re driven by our vision
of Food and Companionship Enriching Life and our approach to
sustainability, Elanco Healthy Purpose™– all to advance the health
of animals, people, the planet and our enterprise. Learn more at
www.elanco.com.
i FDA Conditionally Approves First Drug for Anemia in Cats with
Chronic Kidney Disease | FDA
ii Chalhoub S, et al. Anemia of renal disease: what it is, what
to do and what's new. J Feline Med Surg. 2011;13(9):629-40.
iii Boyd LM, et al. Survival in cats with naturally occurring
chronic kidney disease (2000-2002). J Vet Intern Med.
2008;22:1111-17
Elura, Varenzin, Elanco and the diagonal bar logo are trademarks
of Elanco or its affiliates. @2023 Elanco or its affiliates.
PM-US-23-0888
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Elanco Investor Contact: Katy Grissom (317) 273-9248
kathryn.grissom@elancoah.com
Elanco Media Contact: Season Solorio (765) 316-0233
season.solorio@elancoah.com
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