Elanco Animal Health Incorporated announced that its veterinary dermatology treatment Zenrelia (ilunocitinib) has received a positive opinion from the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP), setting the stage for marketing authorization across the European Union within the next 60 days.
The CVMP's positive recommendation specifically highlighted "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 committee based its recommendation on demonstrated quality, safety, and efficacy data, along with a favorable benefit-risk profile.
Regulatory Milestone and Market Expansion
This approval represents a significant milestone in Zenrelia's global rollout strategy. According to Dr. Ellen de Brabander, Executive Vice President Innovation and Regulatory Affairs at Elanco, "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."
The company conducted a head-to-head non-inferiority study against the current market standard as part of the EU approval process. Dr. de Brabander expressed satisfaction with the comparative results, stating, "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."
Current Market Presence and Future Plans
Zenrelia is currently available in four major markets: Brazil, Canada, Japan, and the United States. The EU approval will significantly expand the product's geographic reach, with Elanco expecting to launch shortly after receiving final marketing authorization and anticipating product supply in the marketplace before the end of the third quarter.
The company's expansion plans extend beyond the EU, with additional regulatory approvals expected in Australia and the United Kingdom during 2025. This aggressive timeline reflects Elanco's strategy to rapidly bring the treatment to veterinarians worldwide.
Addressing Unmet Medical Need
The approval addresses a significant veterinary medical need, with Dr. de Brabander noting that "millions of itchy dogs unable to find relief" could benefit from this new therapeutic option. The consistent labeling across international markets, excluding the United States, will facilitate veterinary adoption and treatment protocols.
Elanco expects the European Commission to adopt the CVMP's recommendation, with the positive opinion to be published on the committee's official website in the coming days. The company anticipates receiving full marketing authorization within 60 days of the positive opinion.
