Zoetis Offers a Targeted New Approach to Rapidly and Safely Stop the Cycle of Itch and Inflammation Associated with Allergic Skin Disease in Dogs
Zoetis, Inc. (NYSE: ZTS), formerly the animal health business unit of
Pfizer Inc., today announced that the U.S. Food and Drug Administration
(FDA) has approved APOQUEL® (oclacitinib tablet) for the
control of pruritus associated with allergic dermatitis and the control
of atopic dermatitis in dogs at least 12 months of age. Pruritus, or
itching, is the most common sign of allergies in dogs. Developed by
Zoetis, APOQUEL is the first Janus kinase (JAK) inhibitor approved for
veterinary use that targets the itch and inflammation pathway. APOQUEL
provides fast-acting relief from itching and improves inflammation for
the estimated 8.2 million dogs that suffer from short- and long-term
allergic skin conditions.
“Previously available treatments have helped with the management of
allergic skin disease in dogs, but an unmet need still exists for a
treatment that works rapidly and effectively with minimal short- and
long-term side effects,” said Douglas DeBoer, DVM, DACVD, Professor of
Dermatology at the University of Wisconsin-Madison School of Veterinary
Medicine, an expert in veterinary dermatology and allergy. “The approval
of APOQUEL is encouraging because it will provide both veterinarians and
pet owners with a treatment that reduces itch within hours and provides
long term relief of itching and inflammation for dogs without the side
effects of steroids.”
Atopic dermatitis is one of the most common allergies in dogs, affecting
approximately 10 percent of the dog population. Itching caused by an
allergic skin disease can be an acute, short-term condition or can be
recurrent or chronic—all which can impact the quality of life for both
the dog and its owner unless they are controlled with effective
management.
APOQUEL Clinical Trial Results
FDA approval of APOQUEL is based on results of two clinical trials
conducted in the United States which showed that APOQUEL was effective
in the treatment of pruritus associated with allergic dermatitis and for
the control of atopic dermatitis. In a trial of dogs with allergic
dermatitis, treatment success, as defined by owner-assessed decrease in
pruritus, occurred in 67 percent of dogs treated with APOQUEL vs. 29
percent of dogs treated with placebo after one week of treatment. In
both studies, dogs that remained on APOQUEL beyond one week experienced
continuous improvement throughout the course of the study. The frequency
and type of adverse events were similar between APOQUEL- and
placebo-treated dogs in short-term trials. Minimal adverse events were
reported in multiple long-term trials.
In a clinical trial of dogs with atopic dermatitis, treatment success
for pruritus occurred in a significantly greater percentage of the dogs
treated with APOQUEL (66 percent) vs. (4 percent) of dogs treated with
placebo (p<0.0001). APOQUEL effectively reduced both owner-assessed itch
and veterinarian-assessed dermatitis throughout the course of the study.
In clinical studies, the most common side effects observed in dogs
treated with APOQUEL were vomiting and diarrhea. Other reported side
effects included: lethargy, decreased or lack of appetite, skin
irritation or infection, and ear irritation or infection. APOQUEL may
increase the susceptibility to infection and demodicosis and may
exacerbate neoplastic conditions.
About APOQUEL
While most current therapies are broad-based agents, APOQUEL is uniquely
targeted to stop the itch and inflammation associated with allergic skin
disease. It is a selective inhibitor of the Janus kinase (JAK) 1 enzyme,
a protein that is integral to the signaling pathway that results in
itching and inflammation. Its novel mechanism of action on the JAK
enzymes is specifically designed to target the pruritogenic and
proinflammatory pathways involved in the itch cycle, allowing control of
the signs of allergic disease.
Current treatments for allergic skin disease are limiting. In acute and
chronic cases of allergic dermatitis, steroids may effectively reduce
pruritus, but the short- and long-term side effects (including
polydipsia, polyphagia, polyuria, pancreatitis, gastrointestinal
ulceration, lipidemias, diabetes, muscle wasting and iatrogenic
Cushing’s syndrome) and intricate dosing schedules can be challenging to
dogs and their owners.
“The approval of APOQUEL provides a much-needed, new, targeted treatment
choice for dogs that suffer from allergic skin conditions and affords
the damaged skin an opportunity to heal, while allowing the veterinarian
ample time to identify the underlying cause of a dog’s allergic
disease,” said Catherine Knupp, Executive Vice President and President,
Research and Development at Zoetis. “Zoetis is committed to research and
development programs that address the real world challenges
veterinarians face while serving the unmet needs of our veterinary
customers in better ways.”
Discovered and developed by Zoetis, APOQUEL will be available by
prescription only. APOQUEL tablets, dosed at 0.18 to 0.27 mg per pound
(0.4 to 0.6 mg/kg), are administered orally, twice daily for up to 14
days, and then administered once daily for maintenance therapy. APOQUEL
may be administered with or without food.
Zoetis plans to make APOQUEL available to veterinarians by the First
Quarter 2014. During the coming months, Zoetis will be educating
veterinarians on the new science associated with canine allergic
diseases to lay the groundwork for a successful launch. For more
information, please visit www.Apoquel.com.
As the latest addition to the company’s diverse portfolio of companion
animal medicines, this approval signifies an important milestone for
this leading animal health company.
About Zoetis
Zoetis (zō-EH-tis) is the leading animal health company, dedicated to
supporting customers and businesses focused on raising and caring for
livestock and companion animals. Building on a 60-year history as the
animal health business of Pfizer, Zoetis discovers, develops,
manufactures and markets veterinary vaccines and medicines, complemented
by diagnostic products and genetic tests and supported by a range of
services. The company generated annual revenues of $4.3 billion in 2012.
It has more than 9,300 employees worldwide and a local presence in
approximately 70 countries, including 29 manufacturing facilities in 11
countries. Its products serve veterinarians, livestock producers and
people who raise and care for livestock and companion animals in 120
countries. For more information, visit www.zoetis.com
or www.zoetisus.com.
Important Safety Information
APOQUEL® should not be used in dogs less than 12 months of
age or in dogs with serious infections. APOQUEL may increase the
susceptibility to infection and demodicosis and may exacerbate
neoplastic conditions. APOQUEL has not been evaluated in combination
with systemic immunosuppressive agents such as glucocorticoids or
cyclosporine. APOQUEL should not be used in breeding dogs, or pregnant
or lactating dogs. The most common side effects seen in dogs
administered APOQUEL were vomiting and diarrhea. APOQUEL has been safely
used in conjunction with other common medications including antibiotics
and parasiticides and with vaccinations.
DISCLOSURE NOTICE
Forward-Looking Statements: This
news release contains forward-looking statements. These
forward-looking statements address various matters including information
about Zoetis products. Each forward-looking statement contained
in this news release is subject to risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statement. Applicable risks and uncertainties
include, among others, regulatory actions and timing of any new product
launches; competitive pressures, environmental trends and conditions;
and the risks identified under the heading "Risk Factors" in our Annual
Report on Form 10-K for 2012, which was filed with the Securities and
Exchange Commission on March 28, 2013, as well as the other information
we file with the SEC. We caution investors not to place
considerable reliance on the forward-looking statements contained in
this news release. You are encouraged to read our filings with
the SEC, available at www.sec.gov,
for a discussion of these and other risks and uncertainties. The
forward-looking statements in this news release speak only as of the
date of this document, and we undertake no obligation to update or
revise any of these statements. Our business is subject to substantial
risks and uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration to
these risks and uncertainties.
Media:
Zoetis
Deron Johnson, 973-660-5567
[email protected]
or
Havas PR
Terese Kelly, 212-367-6860
[email protected]