13/06/2025
Elanco announced a major milestone in helping more itchy dogs that have been unable to find relief reach for zen. Zenrelia™ (Ilunocitinib) has been granted a positive opinion by the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP), paving the way for the product’s marketing authorization in the European Union in the next 60 days.
Elanco is pleased the label will be consistent with other markets outside the United States where the product has already been approved, once the European Commission adopts this recommendation. Elanco expects to launch the product shortly after marketing authorization with supply in the marketplace before the end of third quarter.
The positive opinion notes the recommendation is based on the quality, safety and efficacy Zenrelia demonstrated in the data submitted and the favorable benefit-risk balance.
Zenrelia has been Elanco’s fastest globalized product ever on track for eight major regulatory approvals in just 18 months, with product already available in Brazil, Canada, Japan and the United States and additional approvals in Australia and the United Kingdom expected in 2025.
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Page contents OverviewProduct detailsNews on ZenreliaApplication under evaluationCVMP opinionEuropean Commission decisionOverviewOn 12 June 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion*, recommending the granting of a marketing authorisation for the vete...