Elanco Reinforces Commitment to Veterinary and Pet Owner Education

Core Viewpoint - Elanco Animal Health is committed to enhancing veterinary and pet owner education following a warning letter from the U.S. FDA regarding misleading promotional practices related to its product Zenrelia [1][3][5]. Group 1: FDA Warning Letter - The FDA issued a warning letter to Elanco concerning misleading claims in promotional materials for Zenrelia (ilunocitinib tablets), which misbrands the product under the Federal Food, Drug, and Cosmetic Act [3][11][22]. - The letter highlights that the promotional communications create a misleading impression about the safety and effectiveness of Zenrelia, particularly regarding its use in dogs [11][12][22]. - Elanco is required to address the concerns raised in the letter and submit a written response within 15 working days [26][27]. Group 2: Product Information and Safety - Zenrelia is indicated for controlling itching and inflammation associated with skin allergies in dogs over 12 months of age [6][12]. - The FDA-approved prescribing information includes a boxed warning about the risk of fatal vaccine-induced disease and inadequate immune response to vaccines in dogs receiving Zenrelia [8][12][13]. - The promotional materials omitted critical safety information, including specific timeframes for withholding Zenrelia before and after vaccination, which is misleading for pet owners [16][17][18]. Group 3: Company Response and Future Outlook - Elanco is actively reviewing and updating Zenrelia's promotional materials in response to the FDA's concerns and does not expect these adjustments to materially impact Zenrelia's revenue [4][5]. - The company anticipates accelerating organic constant currency revenue growth in the mid-single digits for 2025 [5]. - Elanco emphasizes its dedication to helping veterinarians and pet owners understand the benefits of Zenrelia while ensuring compliance with regulatory standards [2][4].