Access to canine dermatitis therapy may soon expand to Europe

Photo: Yulia Usikova/Adobe Stock

An immunosuppressant indicated to manage pruritus associated with canine allergic dermatitis and for atopic dermatitis in dogs has received a positive opinion from the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP), which may lead to marketing authorization in Europe by the end of the third quarter of 2025.¹ The ilunocitinib tablets (Zenrelia; Elanco Animal Health) were approved by the FDA for use in the United States in September 2024.²

Ilunocitinib tablets are administered to patients orally once daily. The drug contains a nonselective Janus kinase (JAK) inhibitor.² “It can be used for both short-term acute cases of allergies like flea hypersensitivity or contact allergies or even flare ups in a longer term case, and it could also be used for long term treatment, as in chronic cases of atopy,” Mara Tugel, DVM, veterinary technical marketing-companion animal therapeutics for Elanco, said in a dvm360 interview.³

The CVMP noted the efficacy of ilunocitinib tablets in treating the indicated conditions in its’ opinion, according to Elanco. The CVMP also recommended marking authorization in the European Union based on quality, safety and efficacy demonstrated in the data provided to the committee.¹

“This milestone marks a significant advancement in the expansion of Zenrelia, Elanco’s fastest globalized product with eight major regulatory approvals expected in just 18 months,” Ellen de Brabander, PhD, executive vice president, innovation and regulatory affairs at Elanco, said in a news release.¹ “As part of the EU approval process, Elanco has done a head-to-head noninferiority study versus the marketplace incumbent, and we are very pleased with the result. With millions of itchy dogs unable to find relief, we’re excited to bring this new solution to veterinarians across the EU.”

Ilunocitinib tablets are currently available in Brazil, Canada and Japan, in addition to the US. Elanco noted that, once the European Commission has adopted the CVMP’s recommendation, the EU label will be consistent with other markets outside the United States.¹

The FDA has publicly noted that ilunocitinib tablets are safe and effective when used in accordance to the label. However, the product labeling has a boxed warning stating that dogs should not be vaccinated at least 28 days before and after treatment with the drug. The warning was prompted by fatal vaccine-induced disease and inadequate immune response to vaccines.⁴

Jason B. Pieper, DVM, MS, DACVD, assistant professor at Iowa State University, acknowledged the warning, in a dvm360 interview. He provided insights about the concern about vaccines and addressed adverse effects.⁵

“Zenrelia is a newer drug. The biggest concern with it is it does have a black box warning around vaccinations and suppression and whatnot. But they’ve done some further studies with vaccination, showing that dogs that have previously been vaccinated and are then getting booster vaccines are easily able to achieve tighter levels for the distemper and rabies vaccine. And those were done in much larger studies: 4 times the quantity of dogs [than in] the initial study…. So, from that aspect, I think it’s very safe—I’m not worried about the vaccines aspect with them. I think it’s relatively safe there,” Pieper said.

“Side effects, since it’s also in that JAK inhibitor category and that same first generation of them, I believe that the side effects are relatively low. I have yet to see a side effect with those dogs either,” Pieper added.

In the US, ilunocitinib tablets are available by prescription from a licensed veterinarian and in scored tablets in 4 strengths: 4.8 mg, 6.4 mg, 8.5 mg, and 15 mg. Each tablet strength is available in 10 and 30 count blister packages and 90 count bottles.⁴

“The dose has been optimized to allow for once daily dosing from the start, and this has some really clear advantages for both veterinarians and pet owners,” Tugel said.³ “It’s just simpler. So communicating once daily dosing from the beginning to a pet parent is easier than talking about having to do a dosing change partway through treatment.”

References

1. Elanco receives positive opinion on Zenrelia (ilunocitinib) grom EU’s Committee for Veterinary Medicinal Products (CVMP). News release. June 12, 2025. Accessed June 13, 2025. https://www.prnewswire.com/news-releases/elanco-receives-positive-opinion-on-zenrelia-ilunocitinib-from-eus-committee-for-veterinary-medicinal-products-cvmp-302480544.html
2. FDA Approves New Treatment for Allergic Skin Conditions in Dogs. News release. US Food and Drug Administration. September 19, 2024. Accessed September 19, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-new-treatment-allergic-skin-conditions-dogs?utm_medium=email&utm_source=govdelivery
3. McCafferty C, Tugel M. An overview of Zenrelia. dvm360. October 9, 2024. Accessed June 13, 2025. https://www.dvm360.com/view/an-overview-of-zenrelia
4. McCafferty C. Treatment for allergic skin conditions receives FDA approval. dvm360. September 19, 2024. Accessed June 13, 2025. https://www.dvm360.com/view/zenrelia-receives-fda-approval
5. Bautista-Alejandre A, Pieper JB. Treatment options for moderate to severe atopic dermatitis, and when to use what. dvm360. February 17, 2025. Accessed June 13, 2025.

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