Elanco Animal Health Incorporated has received approval from the US Department of Agriculture (USDA) for Befrena (tirnovetmab), marking the company’s entry into the fast-growing canine dermatology segment with an anti-IL-31 monoclonal antibody therapy for allergic and atopic dermatitis in dogs.

Befrena is designed to deliver long-lasting itch relief with a recommended dosing interval of six to eight weeks following treatment, offering a differentiated option compared with existing therapies in the market that typically require more frequent dosing. Elanco expects to commercially launch Befrena in the first half of 2026.

The USDA approval further reinforces Elanco’s focus on advancing antibody-based therapies and expanding its leadership in canine dermatology and monoclonal antibodies. Befrena becomes Elanco’s second dermatology product approved in less than 18 months, following Zenrelia (ilunocitinib tablets), a once-daily oral JAK inhibitor for the control of itching and inflammation associated with skin allergies in dogs aged 12 months and older.

In September, Elanco also announced updates to the US label for Zenrelia after the Food and Drug Administration concluded that the totality of evidence supported removal of the risk of fatal vaccine-induced disease from modified live virus vaccines from the product labelling. The boxed warning on Zenrelia continues to recommend discontinuation for 28 days to three months prior to vaccination and withholding treatment for at least 28 days after vaccination.

“The animal health sector is increasingly focused on antibody-based therapies, and this approval represents an important step forward in delivering high-impact innovation,” said Dr Ellen de Brabander, executive vice president of research and development at Elanco. “Befrena offers veterinarians and pet owners a long-lasting option to manage allergic itch and improve quality of life for dogs.”

Elanco noted that the approval aligns with insights from its recently launched America’s Itchy Dogs Report, which highlights the widespread prevalence of canine itch and the need for more effective, durable treatment options. The report found that a significant majority of dogs experience itch-related symptoms each year, with pet owners often spending considerable time and money on over-the-counter remedies before seeking veterinary care. Veterinarians reported that delayed treatment frequently results in more severe skin conditions and increased frustration for both pets and owners.

Survey findings also indicated that nearly 70 percent of veterinarians are open to stocking additional dermatology products to better address unmet needs in itch management.

“Veterinarians need more targeted options that address the underlying mode of action while delivering fast and durable relief,” said Dr Griffin, a veterinary dermatologist. “USDA approval of Befrena brings the profession closer to another safe and effective treatment choice, and I look forward to offering it in practice once available.”

Elanco Animal Health Incorporated is a global animal health company focused on developing products and services to prevent and treat disease in farm animals and pets, supporting veterinarians, pet owners, and livestock producers worldwide.