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Zoetis annouce that Apoquel is approved by FDA to treat pruritis

May 17, 2013 in Body systems, Canine, Companies, Dermatology, News, North America, Pharmacology and Therapeutics, Products, USA by Mark Johnston

Zoetis, Inc. announced that the FDA has approved (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. Apoquel is the first Janus kinase (JAK) inhibitor approved for veterinary use that targets the itch and inflammation pathway.

The FDA is approving Apoquel, or the oclacitinib tablet, to treat pruritus, or itching for dogs with allergies, a condition that affects some 8.2 million dogs, according to Zoetis.

“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.

The treatment provides long-term relief of itching and inflammation for dogs without the side effects, according to a company release. The FDA approved the treatment based on the results of two U.S.-based clinical trials.

The studies found the most common side effects in dogs were vomiting and diarrhea. Other reported side effects included lethargy, decreased or lack of appetite, skin irritation or infection, and ear irritation or infection.

The drug, which will require a prescription, should be available to veterinarians by early 2014, according to a company release.