Elanco Receives Positive Opinion on Zenrelia (ilunocitinib) from EU's Committee for Veterinary Medicinal Products (CVMP)

Rhea-AI Summary

Elanco Animal Health (ELAN) has received a positive opinion from the EU's Committee for Veterinary Medicinal Products for Zenrelia (ilunocitinib), a treatment for pruritus associated with allergic dermatitis and atopic dermatitis in dogs. The CVMP's recommendation, based on demonstrated quality, safety, and efficacy, sets the stage for EU marketing authorization within 60 days. Notably, Zenrelia is Elanco's fastest globalized product, with eight major regulatory approvals expected in just 18 months. The company has conducted a successful head-to-head non-inferiority study versus the market incumbent. Already available in Brazil, Canada, Japan, and the United States, Elanco plans to launch Zenrelia in the EU market before the end of Q3 2025, with additional approvals expected in Australia and the UK in 2025.

Positive

• Positive CVMP opinion paves way for EU marketing authorization within 60 days
• Successful head-to-head non-inferiority study versus market incumbent
• Fastest globalized product with 8 major regulatory approvals expected in 18 months
• Already approved in major markets including US, Japan, Canada, and Brazil
• Expected market launch before end of Q3 2025

Negative

• None.

Insights

Pharmaceutical Industry Analyst

EU regulatory win for Elanco's Zenrelia moves key pet allergy drug toward Q3 European launch, strengthening global commercialization strategy.

The positive opinion from the CVMP represents a significant regulatory milestone for Elanco's Zenrelia (ilunocitinib), positioning it for formal EU marketing authorization within 60 days. This development is particularly notable as it expands the global footprint of what Elanco describes as their "fastest globalized product," with eight major regulatory approvals expected in just an 18-month period.

The approval pathway appears streamlined with the CVMP confirming both quality and efficacy in treating pruritus associated with allergic dermatitis and clinical manifestations of atopic dermatitis in dogs. Importantly, Elanco has secured labeling consistent with other international markets, creating regulatory harmony across territories that simplifies marketing and physician education efforts.

A key competitive aspect revealed in this announcement is that Elanco conducted a head-to-head non-inferiority study against the current market leader. While specific data isn't disclosed, the company's positive characterization of these results suggests Zenrelia can effectively compete against established treatments in the companion animal dermatology space.

With commercialization already underway in Brazil, Canada, Japan and the United States, and pending approvals in Australia and the UK, Elanco is executing an aggressive global rollout strategy. The company's confidence in supply chain readiness is evident in their expectation to have product in the European marketplace before the end of Q3, indicating manufacturing scale-up has been successfully managed alongside the regulatory process.

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

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SOURCE Elanco Animal Health

FAQ

What is Elanco's Zenrelia and what is it used for?

Zenrelia (ilunocitinib) is a veterinary medicine used for treating pruritus associated with allergic dermatitis and clinical manifestations of atopic dermatitis in dogs.

When will Zenrelia (ELAN) be available in the European Union?

Elanco expects to launch Zenrelia in the EU market before the end of third quarter 2025, following the expected marketing authorization within 60 days of the CVMP positive opinion.

In which countries is Elanco's Zenrelia currently approved?

Zenrelia is currently approved and available in Brazil, Canada, Japan, and the United States, with expected approvals in Australia and the United Kingdom in 2025.

What were the results of Zenrelia's clinical trials in the EU?

Elanco conducted a head-to-head non-inferiority study versus the market incumbent as part of the EU approval process, with favorable results demonstrating quality, safety, and efficacy.

How many regulatory approvals is Zenrelia expected to receive?

Zenrelia is expected to receive eight major regulatory approvals within just 18 months, making it Elanco's fastest globalized product.