Elanco Receives Positive Opinion on Zenrelia (ilunocitinib) from EU's Committee for Veterinary Medicinal Products (CVMP)
12 juni, 22:17
Elanco Receives Positive Opinion on Zenrelia (ilunocitinib) from EU's Committee for Veterinary Medicinal Products (CVMP)
PR Newswire
GREENFIELD, Ind., June 12, 2025
Company expects approval and product supply in market before the end of third quarter
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.
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.
"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. With millions of itchy dogs unable to find relief, we're excited to bring this new solution to veterinarians across the EU."
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.
The positive opinion will be published on the CVMP's website in the coming days at https://www.ema.europa.eu/en/news .
ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com .
Investor Contact: Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.com
Media Contact: Colleen Parr Dekker (317) 989-7011 colleen.dekker@elancoah.com
SOURCE Elanco Animal Health
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Elanco Receives Positive Opinion on Zenrelia (ilunocitinib) from EU's Committee for Veterinary Medicinal Products (CVMP)
12 juni, 22:17
Elanco Receives Positive Opinion on Zenrelia (ilunocitinib) from EU's Committee for Veterinary Medicinal Products (CVMP)
PR Newswire
GREENFIELD, Ind., June 12, 2025
Company expects approval and product supply in market before the end of third quarter
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.
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.
"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. With millions of itchy dogs unable to find relief, we're excited to bring this new solution to veterinarians across the EU."
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.
The positive opinion will be published on the CVMP's website in the coming days at https://www.ema.europa.eu/en/news .
ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com .
Investor Contact: Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.com
Media Contact: Colleen Parr Dekker (317) 989-7011 colleen.dekker@elancoah.com
SOURCE Elanco Animal Health
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