Elanco Animal Health Incorporated announced that 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. The CVMP recommended granting the marketing authorization based on the quality, safety and efficacy demonstrated in the data submitted and the favorable benefit-risk balance.
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 receiving marketing authorization with supply in the marketplace before the end of third quarter. Zenrelia is already available in Brazil, Canada, Japan and the United States, and the company expects additional approvals in Australia and the United Kingdom in 2025.
