Elanco Announces FDA Approves Improved Zenrelia™ (ilunocitinib tablets) Label, Removing Vaccine-Induced Disease Language

Core Insights - Elanco Animal Health has updated the U.S. Zenrelia label following FDA review, removing the risk of fatal vaccine-induced disease from the labeling, which enhances the product's safety profile [2][3][5] - Zenrelia, a once-daily oral JAK inhibitor for dogs, has been positively received by veterinarians and pet owners, with over half a million dogs treated globally [1][4][5] - The updated label aligns the U.S. version closer to those in other markets like the EU and Japan, reflecting a commitment to ongoing data generation to strengthen the product's label [3][5] Product Performance - Zenrelia has shown remarkable performance in its first year, now available in multiple countries including the U.S., Canada, and Brazil, with positive real-world outcomes reported by veterinarians [4][5] - More than 90% of U.S. veterinarians are aware of Zenrelia, and 80% of clinics reordered the product after experiencing its results [7] Safety and Efficacy - The totality of evidence supports Zenrelia's safety and efficacy when used according to label directions, with ongoing studies published in veterinary journals confirming its effectiveness [3][6] - The updated label includes a Boxed Warning advising on the timing of Zenrelia administration relative to vaccinations to mitigate risks of inadequate immune response [2][11] Veterinary Community Feedback - Veterinarians are increasingly using Zenrelia as a first-line treatment for allergic dermatitis, particularly during allergy seasons, indicating its growing acceptance in clinical practice [8][9] - The updated label facilitates discussions between veterinarians and pet owners regarding treatment options, enhancing the product's usability in practice [8]