USDA approves new Anti-IL31 monoclonal antibody injection

On December 31, 2025, Elanco Animal Health received approval from the USDA for tirnovetmab (Befrena; Elanco Animal Health), an anti-IL31 monoclonal antibody injection that targets canine allergic and atopic dermatitis. The new product Befrena is recommended in dosing intervals of 6-8 weeks post treatment compared to its competitor that is currently on the market that recommends 4-8 weeks post treatment.

“The animal health sector is increasingly focused on antibody-based therapies, and today’s approval is an important step forward in delivering high-impact innovation that enhances the quality of life for pets,” said Ellen de Brabander, PhD, executive vice president of research & development at Elanco, in an organizational release.1 “We are pleased to offer veterinarians and pet owners Befrena, which delivers long lasting relief to treat dogs with allergic itch.”

According to the release, Befrena is the second dermatology product from Elanco to receive approval in less than 18 months and now joins Zenrelia in its dermatology portfolio. Befrena will launch in the first half of 2026.¹

In 2025, Elanco released its first report highlighting the impact itching has on canine patients, clients, and veterinary teams in its America’s Itchy Dogs Report. The report, made up of findings from multiple surveys of pet owners and veterinarians, revealed that 9 out of 10 dogs in the US are ‘itchy dogs’ and have experienced symptoms of itchiness at some point in the year according to their owners, which is nearly 79 million dogs.² The study also found that clients spend around $400 on over-the-counter remedies and wait 6 weeks before bringing their pet to their veterinarian because they typically try to find solutions at home before seeking veterinary care. Because of this, pets whose owners waited too long to bring them in resulted in raw and infected skin as well as owners who are irritated because they want their pet to have some relief.^3,4

Research coming out of Elanco, according to their release, stated that nearly 70% of veterinarians would be willing to stock another dermatology product in their clinic to help more patients find itch relief.

“Veterinarians need more options for itch relief so they can offer targeted therapy that focuses on mode of action to meet the unique needs of the individual patient to deliver fast, effective and valuable itch relief,” said Joya Griffin, DVM, DACVD, veterinary dermatologist. “USDA approval of Befrena brings veterinarians a step closer to having another beneficial and safe treatment option. I’m excited to collaborate with Elanco and plan to offer this product in my practice when it becomes available.”

To learn more about Befrena, visit the Elanco Animal Health website.

Reference

1. Elanco Receives USDA Approval for Befrena (tirnovetmab), a New Anti-IL31 Monoclonal Antibody Injection Targeting Canine Allergic and Atopic Dermatitis. News release. Elanco Animal Health. December 31, 2025. Accessed January 2, 2026. https://www.elanco.com/us/newsroom/press-releases/befrena-usda-approval
2. Elanco Animal Health. America’s Itchy Dogs. Accessed January 2, 2026. https://assets.elanco.com/0cec44ed-3eaa-0009-2029-666567e7e4de/33474a48-bac3-4fc4-b7fc-3589b88560fb/ElancoItchyDogsReportFINAL.pdf
3. Elanco Animal Health. Data on File.
4. Elanco Animal Health. Data on File.