Elanco Receives USDA Approval for Befrena™ (tirnovetmab), a New Anti-IL31 Monoclonal Antibody Injection Targeting Canine Allergic and Atopic Dermatitis
ElancoElanco(US:ELAN) Prnewswire·2025-12-31 19:00

Core Insights - Elanco Animal Health has received USDA approval for Befrena (tirnovetmab), a new monoclonal antibody injection targeting canine allergic and atopic dermatitis, with a dosing interval of 6 to 8 weeks, which is longer than the competitor lokivetmab's 4 to 8 weeks [1][2][4] - The approval of Befrena is part of Elanco's strategy to enhance its leadership in canine dermatology and monoclonal antibodies, marking its second dermatology product approval in less than 18 months [2][4] - Elanco plans to launch Befrena in the first half of 2026, further expanding its product offerings in the $1.3 billion U.S. canine dermatology market [2][4] Company Developments - Elanco's commitment to innovation is highlighted by the launch of the America's Itchy Dogs Report, which reveals that 90% of dogs in the U.S. experience itchiness, leading to significant spending on over-the-counter remedies by pet owners [3] - The company has also improved the labeling of its existing product Zenrelia, a once-daily oral JAK inhibitor for skin allergies, following FDA review [2][3] Industry Context - The animal health sector is increasingly focusing on antibody-based therapies, with a significant demand for effective itch relief options among veterinarians [3][4] - Nearly 98% of veterinarians treat dogs for atopic dermatitis, indicating a widespread concern and a substantial market opportunity for new treatments like Befrena [4]

Elanco Receives USDA Approval for Befrena™ (tirnovetmab), a New Anti-IL31 Monoclonal Antibody Injection Targeting Canine Allergic and Atopic Dermatitis - Reportify