Elanco Achieves Key European Approval for Zenrelia Launch

Elanco Makes Strides with Zenrelia Approval in Europe

Elanco Animal Health Incorporated (NYSE: ELAN) is thrilled to announce that Zenrelia™ (ilunocitinib) has received a positive opinion from the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP). This news heralds the potential marketing authorization for the innovative product within a swift timeframe of 60 days.

The CVMP's positive assessment emphasizes the efficacy of Zenrelia in alleviating pruritus related to allergic dermatitis in dogs, as well as treating clinical manifestations of atopic dermatitis. Importantly, this recommendation was founded on robust data showcasing quality, safety, efficacy, and an advantageous benefit-risk balance. Elanco is eager to ensure that the labeling will align with approvals in other regions where the product is already in circulation—once the European Commission formalizes the endorsement.

Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs at Elanco, expressed enthusiasm about this significant milestone, indicating that Zenrelia is the company’s most rapidly globalized product, with eight major regulatory approvals anticipated over a mere 18-month span. She highlighted the successful results from a head-to-head non-inferiority study against existing treatments in the market, declaring, "With millions of itchy dogs struggling for comfort, we're excited to offer a new solution to veterinarians across Europe."

Looking ahead, Elanco anticipates launching Zenrelia soon after receiving marketing authorization, with plans for availability in the marketplace before the present quarter concludes. The product is currently on sale in countries such as Brazil, Canada, Japan, and the United States, with further approvals expected in Australia and the United Kingdom next year.

These developments mark a pivotal moment for Elanco as it seeks to enhance the quality of life for pets through advanced medical solutions. The company’s path is characterized by innovation and a deep commitment to animal health, aligning with its vision of enriching lives through food and companionship.

ABOUT ELANCO

Elanco Animal Health Incorporated (NYSE: ELAN) stands as a leading figure in the animal health industry, dedicated to developing and delivering advanced products and services to effectively prevent and treat diseases in both farm animals and pets. With an esteemed legacy exceeding 70 years, Elanco is passionate about advancing animal health while also making a positive impact in communities around the world. Driven by the Elanco Healthy Purpose™ sustainability strategy, the company aims to optimize the health of animals, the well-being of people, and the health of our planet. For more information, visit www.elanco.com.

Investor Contact: Tiffany Kanaga, (765) 740-0314

Media Contact: Colleen Parr Dekker, (317) 989-7011

Frequently Asked Questions

What is Zenrelia?

Zenrelia (ilunocitinib) is a prescription medication approved for the treatment of pruritus associated with allergic dermatitis in dogs.

What recent development did Elanco announce?

Elanco announced that Zenrelia has received a positive opinion from the CVMP, which is a significant step toward marketing authorization in Europe.

When does Elanco expect Zenrelia to be available in Europe?

Elanco anticipates launching Zenrelia shortly after receiving marketing authorization, with plans for product supply in the market before the end of the current quarter.

In which countries is Zenrelia already available?

Zenrelia is currently available in Brazil, Canada, Japan, and the United States.

How is Zenrelia expected to benefit dogs?

Zenrelia is expected to provide relief to dogs suffering from itchy skin due to allergic conditions, helping improve their overall comfort and quality of life.

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