News Details

European Commission Approves APOQUEL® (oclacitinib tablet) for Treatment of Itch Associated with Allergic Dermatitis and Clinical Manifestations of Atopic Dermatitis in Dogs

September 19, 2013

Zoetis Offers a Targeted Approach that Rapidly, Sustainably and Safely Breaks the Cycle of Itch and Inflammation Associated with Allergic Skin Diseases in Dogs

 

FLORHAM PARK, N.J. – September 19, 2013 – Zoetis, Inc. (NYSE: ZTS), formerly the animal health business unit of Pfizer Inc., today announced that following a positive opinion from the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission has approved APOQUEL® (oclacitinib tablet) in the European Union for the treatment of pruritus associated with allergic dermatitis and the treatment of clinical manifestations of atopic dermatitis in dogs at least 12 months of age. Developed by Zoetis, APOQUEL® is the first Janus kinase (JAK) inhibitor approved for veterinary use. It inhibits the function of a variety of allergic, itch and pro-inflammatory cytokines dependent on JAK enzyme activity and thus stops the cycle of itch and inflammation occurring in skin allergies. APOQUEL® provides rapid and sustained itch relief and improves skin lesions for the estimated 5 million dogs in Europe that suffer from short- and long-term allergic skin conditions.

“Apoquel® is a targeted treatment that specifically inhibits JAK-dependent cytokines involved in allergic skin disease in dogs,” said Michael Stegemann, Senior Director Global Development Organisation at Zoetis. “Its rapid anti-pruritic effect along with its anti-inflammatory properties provide fast relief to dogs. Relief from itch and inflammation is maintained in dogs receiving long-term treatment with APOQUEL®. This exciting innovation molecule offers, quick, effective, and sustained itch relief; improves skin lesions continuously and can be used safely short or long-term.“

Pruritus, or itch, is the most common sign of allergic skin disease in dogs. Itch associated with allergic skin diseases can occur on an acute, seasonal, recurrent or chronic basis—all which can impact the quality of life of both the dog and its owner unless it is rapidly and effectively controlled with symptomatic therapy.

 

APOQUEL Clinical Trial Results

Zoetis researchers have made major discovery findings around the mechanism of itch in allergic skin diseases, and the role of allergic, pro-inflammatory and itch cytokines that signal through the JAK pathway. Those findings have supported the development of APOQUEL®.

In clinical trials, APOQUEL® demonstrated safety and efficacy for the treatment of itch and resulted in improved skin lesions in dogs diagnosed with a number of allergic skin diseases as well as atopic dermatitis and treated either short or long term.   The decrease in itch scores was observed by pet owners as soon as 24 hours after administration, the first observation time point, and itch continued to decrease compared to baseline until the end of the study.  Skin lesions scores assessed by veterinarians were significantly improved after one week and continued to improve long term during the studies (4 months).

In those field 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. 

About  APOQUEL

While most current therapies are broad-based agents, APOQUEL® presents an innovative mode of action that allows targeting of itch and inflammation at its source when associated with allergic skin disease. It is an inhibitor of the Janus kinase (JAK) enzyme, a protein that is integral to the signaling pathway of cytokines that are pro-inflammatory or have a role in allergic and itch response.

Its novel mechanism of action on the JAK enzyme is specifically designed to target the pruritogenic and pro-inflammatory pathways involved in the itch cycle, allowing effective reduction of itch and improvement of the clinical signs of allergic skin diseases and atopic dermatitis.

 

Current treatments for itch are limited. In acute and chronic cases, steroids may effectively reduce pruritus, but their short- side effects (polyphagia polydipsia, polyuria and panting) and long-term side complications (including pancreatitis, gastrointestinal ulceration, lipidemia, diabetes, muscle wasting and iatrogenic Cushing’s syndrome) and complex dosing schedules can be a real challenge to both dogs and their owners. 

 

APOQUEL® will be available on prescription by a veterinarian only. APOQUEL® tablets, dosed at 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 if medium to long term treatment is required, such as in dogs with seasonal skin allergy and atopic dermatitis. APOQUEL® may be administered with or without food. During treatment with APOQUEL®, diagnosis and management of the underlying causes of the allergic dermatitis should be implemented as well. APOQUEL has been safely used in conjunction with other medications including antibiotics, parasiticides and anti-inflammatories commonly used in dogs.  

APOQUEL® represents the latest addition to the company’s dermatology portfolio of companion animal medicines.  Zoetis plans to make APOQUEL® available to veterinarians in the European Union in 2014. During the coming months, Zoetis will be working with veterinarians on the new science and research findings around itch and canine allergic diseases. For more information, please visit www.zoetis.com, www.itchcycle.com.

About  Zoetis

Zoetis (zō-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. 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 technical services, with a focus on both farm and companion animals. In 2012, the company generated annual revenues of $4.3 billion. With approximately 9,300 employees worldwide at the beginning of 2013, Zoetis has 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 farm and companion animals in 120 countries. For more information on the company, visit www.zoetis.com.

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.

 

 

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Media Contacts:                                             

Karima Yadi

Zoetis

karima.yadi@zoetis.com                                          

 

Anne-France Quentric

Zoetis

+33.158075499

anne-france.quentric@zoetis.com     

 

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