FDA approves Apoquel chewable for pruritus, control of atopic dermatitis in dogs
Zoetis Inc. announced on June 13 that the U.S. Food and Drug Administration (FDA) has approved Apoquel Chewable (oclacitinib chewable tablet) for the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
Apoquel Chewable, the first and only chewable treatment for the control of allergic itch and inflammation in dogs in the U.S. is expected to have comparable efficacy to original Apoquel (oclacitinib tablet) after the first dose. According to a news release, the chewable's formulation may enhance medication compliance and therefore improve outcomes for dogs.
Pruritus is the most common sign of allergies in dogs, and atopic dermatitis (environmental allergies) affects up to 15% of the dog population. Itching caused by allergic skin disease can be an acute, short-term condition or can be recurrent, seasonal or chronic, impacting the quality of life for both the dog and owner.
In a study, 65% of pet owners reported challenges in giving their dogs tablet-based treatments. With the approval of Apoquel Chewable, pet owners will have a new treatment option to help improve medication compliance while helping to maintain the human-animal bond by making daily dosing less stressful.
Andy Hillier, director of Dermatology Medical Strategy and Field Specialists at Zoetis, said in the news release that over the last decade, the company has been at the forefront of addressing allergic and atopic dermatitis in dogs with Apoquel.
"The FDA approval of Apoquel Chewable offers veterinarians an additional treatment option, enabling them to provide individualized care for their patients that also meet pet owners’ needs,” he said. Hillier cited the study referenced above about pet owners preferring a chewable, too.
"We believe that this, combined with the high palatability of a flavored chewable tablet, will lead to increased compliance, so that pet owners can spend more quality time with their dogs,” he said.
Palatability field trial results
In the U.S. field trial, 1,662 doses of Apoquel Chewable were administered to 120 pet dogs. Apoquel Chewable tablets were administered twice daily for up to 14 days at the labeled dose range of 0.4–0.6 mg/kg with palatability assessed for the first seven days of dosing. The study found that a total of 1,522 doses (91.6%) of Apoquel Chewable were accepted voluntarily within five minutes.
Dr. Ashley Bourgeois, DVM and a board-certified veterinary dermatologist, said in the news release that she often hears from frustrated pet owners who report that their dog resists accepting an unflavored tablet, even when it is hidden inside of food or if the dog previously took the pill. This can have a significant impact on the quality of life for dogs living with atopic dermatitis, she said.
“The availability of a flavored chewable tablet is a major step forward for many pet owners in that it is expected to provide comparable efficacy to the original tablet after the first dose, but in a palatable formulation,” said Bourgeois.
In May 2023, Zoetis celebrated the 10-year anniversary of Apoquel, the most prescribed medicine for effective relief of allergic itch and inflammation in dogs due to atopic and allergic dermatitis. Over the past decade, Apoquel has revolutionized the canine allergic dermatitis landscape, providing veterinarians with a treatment option for fast relief from allergic itch. Veterinarians have prescribed Apoquel to over 13 million dogs, and it is number one in owner and veterinarian satisfaction for oral medications for allergic dermatitis in dogs.
About Apoquel brand - safety information
Do not use Apoquel or Apoquel Chewable in dogs less than 12 months of age or those with serious infections. Apoquel and Apoquel Chewable may increase the chances of developing serious infections and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. Apoquel and Apoquel Chewable have not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. Apoquel and Apoquel Chewable have been used safely with many common medications including parasiticides, antibiotics and vaccines. See full Prescribing Information for Apoquel and Apoquel Chewable.
Indications
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
About Zoetis
As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After innovating ways to predict, prevent, detect, and treat animal illness for more than 70 years, Zoetis continues to stand by those raising and caring for animals worldwide – from veterinarians and pet owners to livestock farmers and ranchers. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $8.1 billion in 2022 with approximately 13,800 employees. For more information, visit www.zoetis.com.
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