Zoetis has 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. The company says 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.
Michael Stegemann, Senior Director Global Development Organisation at Zoetis said: "Apoquel is a targeted treatment that specifically inhibits JAK-dependent cytokines involved in allergic skin disease in dogs. 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."
Zoetis says that 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 veterinary surgeons were significantly improved after one week and continued to improve long term during the studies (4 months). In these 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.
Apoquel will be a POM-V treatment. 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.
Zoetis plans to make Apoquel available to veterinary surgeons in the European Union during 2014. Meantime, Zoetis says it will be working with vets on the new science and research findings around itch and canine allergic diseases. For more information, visit www.zoetis.com, www.itchcycle.com.
PS: Whilst you're here, take a moment to see our latest job opportunities for vets.