Business
Elanco Receives Positive Opinion on Zenrelia (ilunocitinib) from EU's Committee for Veterinary Medicinal Products (CVMP)
Elanco Animal Health Incorporated (NYSE: ELAN) announced today 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.
About this update from Elanco Animal Health Incorporated
[{"type":"text","content":"Company expects approval and product supply in market before the end of third quarter","length":85,"tagName":"p","attribs":{}},{"type":"text","content":"GREENFIELD, Ind., June 12, 2025 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) announced today 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.","length":376,"tagName":"p"},{"type":"image","alt":"Elanco logo (PRNewsfoto/Elanco Animal Health)","displaySize":"","headline":null,"caption":"Elanco logo (PRNewsfoto/Elanco Animal Health)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":267,"url":"https://media.zenfs.com/en/prnewswire.com/3e0d7ba65d33b7150e97f71c77abc8af"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/LM_acgCT_vHsVMsjwpFxgA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ3MTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/3e0d7ba65d33b7150e97f71c77abc8af","width":400,"height":267}},"href":"https://mma.prnewswire.com/media/2309278/Elanco_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The positive opinion notes, "The benefits of Zenrelia are its efficacy in the treatment of pruritus associated with allergic dermatitis in dogs, and the treatment of clinical manifestations of atopic dermatitis in dogs." 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.","length":599,"tagName":"p"},{"type":"text","content":""This milestone marks a significant advancement in the expansion of Zenrelia, Elanco's fastest globalized product with eight major regulatory approvals expected in just 18 months," said Dr. Ellen de Brabander, Executive Vice President Innovation and Regulatory Affairs at Elanco. "As part of the EU approval process, Elanco has done a head-to-head non-inferiority study versus the marketplace incumbent, and we are very pleased with the result....