Treatment for allergic skin conditions receives FDA approval

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The FDA announced earlier today that ilunocitinib tablets (Zenrelia; Elanco) has received its approval. The latest drug from Elanco will be used to control pruritus associated with allergic dermatitis as well as controlling atopic dermatitis in canines at least a year of age.

This ilunocitinib tablet is an immunosuppressant that is given to patients orally once a day, with or without food. The drug contains a nonselective Janus kinase (JAK) inhibitor and is the second JAK inhibitor the FDA has approved for this indication.¹

“Today is a historic day for Elanco with our first of several expected entries into the fast-growing global canine dermatology market, bringing veterinarians and pet owners a highly effective new solution that got more dogs back to normal levels of itch in a head-to-head study with the current JAK inhibitor on the market2*,” Jeff Simmons, President and CEO, Elanco Animal Health, said in a news release.²

“We are excited to offer veterinarians and pet owners a solution that can relieve the burdens of itch, while also becoming just the second animal health company to offer veterinarians a comprehensive portfolio, including parasiticides, vaccines, pain and other therapeutics, and now, dermatology,” he added.

Elanco conducted a head-to-head noninferiority study as a way to compare the safety of oclacitinib tablets (for canine itch relief) and ilunocitinib tablets for submission in the European Union. The study was randomized and double blind with 338 client-owned canine patients that had atopic dermatitis. The study was conducted over 25 study sites within 4 countries. The findings displayed that a single dose of ilunocitinib tablets daily is at least as effective as the market incumbent JAK inhibitor at the primary end point on Day 28.

The safety of ilunocitinib tablets was demonstrated in multiple clinical and toxicity safety studies. According to Elanco, the drug’s required margin on the safety study was conducted in health dogs given placebos, 1, 2, 3, or 5 times the label dose daily for 6 months. All the dogs completed the study with no serious adverse effects.

The FDA shared in their release that ilunocitinib tablets are safe and effective when used in according to the label, but 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. This warning is because of fatal vaccine-induced disease and inadequate immune response to vaccines.

“Zenrelia has been demonstrated to be safe and highly effective in a number of studies,” Mara Tugel, DVM, dermatology medical strategic lead at Elanco, said in the release.¹ “We recognize that veterinarians need clinically relevant data to guide treatment choices, and plan to pursue additional studies to evaluate vaccine response in Zenrelia-treated dogs. We will continue to work to improve the label over time.”

Ilunocitinib tablets are only available by prescription from a licensed veterinarian and will be available 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.¹ Veterinarians can now order ilunocitinib tablets and learn more at Zenreliaforvets.com.

On Friday, September 20, 2024, Elanco will hold a conference call at 8:00 AM EST to discuss this approval with the investment community and any other interested parties. The conference call will also have a live webcast that can be accessed through the link posted on Elanco’s website and a replay will be available on the site shortly after the completion of the call.

Reference

1. 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
2. Elanco Announces FDA Approval and Launch of Zenrelia™ (ilunocitinib tablets), Offering An Effective, Safe Solution in Canine Dermatology. News release. Elanco Animal Health Incorporated. September 19, 2024. Accessed September 29, 2024. https://www.elanco.com/en-us/news/elanco-announces-fda-approval-and-launch-of-zenreliatm-ilunocitinib-tablets