In May 2013 the “U.S. Food and Drug Administration 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.” 1 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. 1
Apoquel entered the market on January 20th, 2014. Apoquel was highly successful and in July 2014 Zoetis could no longer produce enough medication. Zoetis made plans to increase the production of Apoquel but told customers that it will take approximately nine months for production to be increased. Zoetis gave priority to pets already on the medication to allow them to continue therapy and did not fulfill new orders for pets not on the medication. Steven Leder, Senior Vice President of Zoetis’ U.S. Companion Animal Division, said “I apologize for the frustration and disappointment this situation is causing you and the discomfort to dogs that need the product but cannot access Apoquel.”
In February 2015, acquired Abbott Animal Health and this should allow the company to increase production of Apoquel. Zoetis CEO, Juan Ramon Alaix said, “We expect to see stronger performance in this area in the future as we significantly increase the supply of Apoquel in April 2015 and continue our investment in discovering, acquiring and launching new products for companion animals.” In order to meet such a strong demand for Apoquel, Zoetis has reduced manufacturing time and increased manufacturing capacity.
Where does the production and distribution of Apoquel stand today? According to the US Zoetis website, “Apoquel (oclacitinib tablet) is now available for purchase to all veterinarians based on predetermined order limits. We will closely monitor purchasing behavior and intend to gradually increase the supply of Apoquel throughout 2015. We are committed to providing a better customer service experience in 2015 and appreciate your patience and understanding throughout the past year.”
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.
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