- Befrena is approved for the treatment of canine allergic and atopic dermatitis, effective for 6–8 weeks per injection.
- The product is Elanco’s second dermatology approval in 18 months, following Zenrelia™ (ilunocitinib).
- Befrena is administered at longer dosing intervals than the current market competitor, lokivetmab.
- The approval strengthens Elanco’s leadership in monoclonal antibodies (mAbs) and the $1.3 billion U.S. canine dermatology market.
- Elanco expects to launch Befrena in the first half of 2026.
A New Option in Canine Dermatology
Elanco Animal Health Incorporated (NYSE: ELAN) announced USDA approval of Befrena™ (tirnovetmab), a novel anti-IL31 monoclonal antibody designed to target canine allergic and atopic dermatitis. The product delivers six to eight weeks of therapeutic effect following a single injection and is approved for use in dogs of any age.
“Antibody-based therapies are reshaping animal health, and today’s approval is an important step forward in advancing innovative, high-impact solutions,” said Dr. Ellen de Brabander, Executive Vice President of Research & Development at Elanco. “Befrena provides long-lasting relief from allergic itch and enhances veterinarians’ ability to personalize dermatologic care.”
Building on Zenrelia and Expanding Dermatology Leadership
Befrena’s approval follows that of Zenrelia™ (ilunocitinib), Elanco’s once-daily oral JAK inhibitor for controlling pruritus and inflammation associated with canine skin allergies. The back-to-back approvals underscore Elanco’s dermatology strategy and its growing monoclonal antibody portfolio.
In September 2025, the FDA approved label updates for Zenrelia, removing the warning regarding fatal vaccine-induced disease risk from modified live vaccines, following a comprehensive safety review.
The Need for More Options in Dermatologic Care
Canine allergic and atopic dermatitis remains one of the most common conditions seen in companion animal practice. Research cited by Elanco shows that 98% of veterinarians routinely treat dogs for atopic dermatitis, and itchy dogs represent nearly 20% of their caseload.
Elanco’s America’s Itchy Dogs Report highlights the impact of chronic itch on both pets and their owners. According to the findings, 9 in 10 dogs experience itch symptoms annually, with pet owners spending roughly $400 on over-the-counter remedies before seeking veterinary care—often after six weeks of discomfort.
“Veterinarians need additional tools to manage itch effectively,” said Dr. Griffin, a veterinary dermatologist. “Befrena provides a targeted, safe, and durable option that will help clinicians tailor therapy based on each patient’s unique needs.”
Market Impact and Availability
With a launch expected in the first half of 2026, Befrena joins Elanco’s expanding dermatology and monoclonal antibody portfolio, reinforcing the company’s position in a fast-growing $1.3 billion U.S. canine dermatology market.
Veterinarians can learn more or register for updates and educational webinars at www.BefrenaforVets.com.
Information sourced from Elanco Animal Health’s press release.
