- The first monoclonal antibody authorized for veterinary use in the European Union
- A single injection of Cytopoint treats the clinical signs of atopic dermatitis in dogs, including itch and inflammation, for up to one month
- Targets and neutralizes canine interleukin-31 (cIL-31), a key cytokine involved in stimulating itch in dogs with atopic dermatitis
- Joins Zoetis’ Apoquel ® (oclacitinib tablet), giving veterinarians two targeted treatment options for canine patients with atopic dermatitis
Zoetis
Inc. (NYSE:ZTS) today announced that the European Commission has
granted the company marketing authorization for Cytopoint (lokivetmab),
the first monoclonal antibody (mAb) therapy approved in the European
Union for veterinary use. Cytopoint is indicated to treat the clinical
signs, including itching and inflammation, associated with atopic
dermatitis in dogs of any age weighing 3 kilograms or more. Cytopoint
targets and neutralizes canine interleukin-31 (cIL-31), a key protein
involved in triggering itch in dogs. Administered by injection once
monthly, Cytopoint provides fast, long-lasting relief of itching – the
hallmark sign of the allergic skin condition atopic dermatitis in dogs –
and the inflammation and lesions it causes. Cytopoint helps improve the
long-term health and quality of life for dogs suffering from atopic
dermatitis and eases the related frustration and concern of their owners.
“My personal experience with Cytopoint showed impressive speed of
efficacy, significantly reducing itch in dogs from 24 hours onwards,”
said Dr. Emmanuel Bensignor, a specialist in veterinary dermatology in
Paris, France, who participated in field studies conducted in
Europe. “Atopic dermatitis is a very common disease in dogs, and the
owners I meet are desperate to find a rapid, reliable and safe solution
for their suffering dogs. With its once monthly injection, I believe
that Cytopoint has the potential to meet pet owners’ needs for its
convenience. European veterinary dermatologists and veterinarians will
now have access to a new therapeutic class via this first monoclonal
antibody treatment for veterinary use. It is a very exciting innovation
which brings a notable improvement to the health and quality of life of
the dogs and happiness to their families.”
“We are honored to be granted the first approval of a monoclonal
antibody therapy for veterinary use by the European Commission,” said
Dr. Catherine Knupp, Executive Vice President and President, Research
and Development at Zoetis. “As the first such therapy to provide relief
from atopic dermatitis, we are once again using our science and focus on
our customers’ most pressing challenges to find solutions for an area of
unmet need in animal health.”
According to Dr. Knupp, this innovation results from a deeper scientific
understanding of the causes of allergic skin conditions in dogs at the
molecular level and the development of novel, targeted, effective
treatments based on these new insights. “Veterinarians have told us that
allergic dogs and their owners have a variety of needs and we are proud
to offer them two innovative solutions with Cytopoint and our oral
tablet therapy Apoquel. These first-in-class medicines give
veterinarians effective, safe options to customize atopic dermatitis
treatment for canine patients, and I am very proud of the breakthrough
treatments our Zoetis team has developed,” said Dr. Knupp.
Apoquel is the first Janus kinase inhibitor approved by the European
Commission for veterinary use to provide fast and safe itch relief for
dogs at least 12 months of age that have symptoms associated with
allergic dermatitis triggered by food, fleas or contact allergens, as
well as atopic dermatitis.
About Cytopoint
Cytopoint is a ready-to-use, sterile solution for injection containing
the mAb lokivetmab. It is specifically designed to target and neutralize
cIL-31, a key cytokine (protein important in cell to cell communication)
involved in triggering itching associated with canine atopic dermatitis.
It works by mimicking the activity of natural antibodies to selectively
bind and neutralize IL-31, thus interrupting the itch cycle in atopic
dogs.
Cytopoint begins working within eight hours and delivers one month of
relief from the clinical signs of canine atopic dermatitis, allowing
damaged skin the chance to heal. In clinical studies submitted to
European Medicines Agency, treatment with Cytopoint at a minimum dose of
1 mg/kg resulted in a clear benefit in the reduction of pruritus
(itching) and showed a beneficial effect on the reduction of disease
severity as evaluated by scoring the skin lesions.
It is safe for dogs of any age, even those with concomitant diseases,
and can be used with many common medications, including vaccines.
Moreover, because of the precision and specificity with which it acts to
target and neutralize cIL-31, it has been demonstrated not to interfere
with the immune response, meaning that it did not induce unintended
immunosuppression or enhancement.
Cytopoint functions like normally occurring antibodies and is eliminated
via normal protein degradation pathways in the same way, with minimal
involvement of the liver or kidneys.
Cytopoint Prescribing Information
The recommended minimum efficacious dose for the treatment of clinical
manifestations of atopic dermatitis in dogs is 1 mg/kg, which can be
repeated monthly. Cytopoint will be available in single dose vials
containing 10, 20, 30 or 40 mg/kg of lokivetmab.
About Atopic Dermatitis
Itching is among the most frequent complaints of pet owners, affecting
roughly 1 in 6 dogs whose owners seek veterinary help.1 There
are a number of factors that can trigger an itch reaction, such as
infections, allergies and parasites—and approximately 15-20 percent of
all itchy dogs will be diagnosed with atopic dermatitis.1
Cytopoint will be available beginning in July to veterinary dermatology
specialists through an early experience program and to veterinarians in
European Union countries in the fall. It brings mAb therapy – a
fast-growing area in human medicine – for the first time to
veterinarians for use to treat atopic dermatitis in canine patients. For
more information, click here.
About Zoetis
Zoetis
is the leading animal health company, dedicated to supporting its
customers and their businesses. Building on more than 60 years of
experience in animal health, Zoetis discovers, develops, manufactures
and markets veterinary vaccines and medicines, complemented by
diagnostic products, genetic tests, biodevices and a range of services.
Zoetis serves veterinarians, livestock producers and people who raise
and care for farm and companion animals with sales of its products in
more than 100 countries. In 2016, the company generated annual revenue
of $4.9 billion with approximately 9,000 employees. For more
information, visit
www.zoetis.com
.
DISCLOSURE NOTICES
Forward-Looking Statements: This press release contains
forward-looking statements, which reflect the current views of Zoetis
with respect to business plans or prospects, future operating or
financial performance, expectations regarding products, and other future
events. These statements are not guarantees of future performance or
actions. Forward-looking statements are subject to risks and
uncertainties. If one or more of these risks or uncertainties
materialize, or if management's underlying assumptions prove to be
incorrect, actual results may differ materially from those contemplated
by a forward-looking statement. Forward-looking statements speak only as
of the date on which they are made. Zoetis expressly disclaims any
obligation to update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise. A further list
and description of risks, uncertainties and other matters can be found
in our Annual Report on Form 10-K for the fiscal year ended December 31,
2016, including in the sections thereof captioned “Forward-Looking
Statements and Factors That May Affect Future Results” and “Item 1A.
Risk Factors,” in our Quarterly Reports on Form 10-Q and in our Current
Reports on Form 8-K. These filings and subsequent filings are available
online at
www.sec.gov
,
www.zoetis.com
,
or on request from Zoetis.
1 Data on file, IL-31 Positioning Research. IPSOS 2014. IL-31
Pricing Research. SKP. 2015, Zoetis LLC.
Zoetis Inc.
Media:
Anne-France Quentric, +32 227468311 (o)
anne-france.quentric@zoetis.com
or
Elinore White, 1-973-443-2835 (o)
elinore.y.white@zoetis.com
or
Investor:
Steve Frank, 1-973-822-7141 (o)
steve.frank@zoetis.com