Zoetis Announces U.S. Label Update for Librela® (bedinvetmab injection), a Treatment to Control Canine Osteoarthritis (OA) Pain

Rhea-AI Summary

Zoetis announced an updated U.S. label for Librela® (bedinvetmab injection), their once-monthly injectable treatment for canine osteoarthritis (OA) pain. The label update follows post-approval experience since the product's U.S. launch in October 2023, which has treated over one million dogs domestically.

The company maintains confidence in Librela's safety and effectiveness, noting that globally, with nearly 25 million doses distributed, adverse events remain rare - less than 10 occurrences per 10,000 treated animals. The product has been improving dogs' lives in Europe for four years.

Zoetis will immediately implement the updated label and Client Information Sheet, making them available on their website and to veterinarians. The company has conducted over 1,000 medical education webinars and provides extensive resources to support veterinarians in treating OA in dogs.

Positive

• Over 1 million dogs treated in the U.S. since October 2023 launch
• Global distribution of nearly 25 million doses
• Low adverse event rate (less than 0.1%)

Negative

• Label update required based on post-approval experience, indicating potential safety concerns

Insights

Pharmaceutical Industry Analyst

The label update for Librela represents a significant but routine development in Zoetis's $77.4B animal health business. Several key factors make this announcement particularly noteworthy:

The rapid market penetration of Librela is remarkable - achieving 1 million treated dogs in just 4 months since U.S. launch demonstrates exceptional commercial execution and strong market demand. For context, this adoption rate significantly outpaces typical veterinary drug launches.

The timing and proactive nature of this label update is strategically sound. By implementing changes based on real-world data before any major issues arise, Zoetis is protecting its estimated $1B+ peak sales potential for Librela. This approach typically helps maintain prescriber confidence and minimizes potential market disruption.

The global safety profile, with 25 million doses administered and adverse events remaining below 0.01%, provides robust evidence supporting the product's safety. This extensive dataset should help maintain veterinarian confidence during the label update transition.

Commercially, Zoetis's comprehensive support program (1,000+ medical education webinars, regular office hours) demonstrates best-in-class commercial execution. This level of professional education typically correlates with sustained market growth and reduced impact from label updates.

The broader context is important - the companion animal therapeutics market continues to show strong growth, with premium-priced innovative products like Librela driving sector expansion. This label update is unlikely to materially impact Zoetis's market leadership or the product's commercial trajectory.

Zoetis Plans to Immediately Implement Updated Label Based on U.S. Post-Approval Experience with Librela

Company Remains Confident in the Safety and Effectiveness of Librela and Reaffirms Its Commitment to Supporting Veterinarians and Pet Owners in Helping Dogs with OA Live with Less Pain and Greater Mobility

More Than One Million Dogs in the U.S. Have Been Treated with Librela Since Its Launch in the U.S. in October 2023

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Zoetis Inc. today announced that it has updated the U.S. label for Librela^® (bedinvetmab injection), following its submission of a supplement to the U.S. Food and Drug Administration (FDA). This supplement includes updated labeling based on post-approval experience with Librela in the U.S. since the product launched over a year ago. The company remains confident in the safety and effectiveness of Librela and plans to implement the updated label immediately in its ongoing commitment to supporting veterinarians and pet owners in the use of Librela. The revised label can be found by clicking here.

Librela, a once-monthly injectable monoclonal antibody for the control of pain associated with osteoarthritis (OA) in dogs, was approved for use by the FDA in May 2023 and launched in the U.S. in October 2023. It has been used to treat more than one million dogs in the U.S.

Zoetis has been engaged with the FDA to review post-launch, real-world drug experience data reported to the agency and collected through Zoetis’ pharmacovigilance monitoring of its products’ safety and efficacy. Label updates in the pharmaceutical space are not uncommon, particularly in the first few years after a launch in response to real-world experience data.

Since its launch in Europe four years ago, Librela has improved the lives of millions of dogs suffering from OA pain. With nearly 25 million doses¹ distributed globally, no individual adverse event sign has been reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) – representing less than 10 occurrences per 10,000 treated animals (where one dose equals one treated animal)².

“Pets are at the center of everything we do at Zoetis, and we are constantly working to support veterinarians and pet parents in ensuring they have the resources to make informed decisions for the animals in their care,” said Dr. Richard Goldstein, DVM, DACVIM, DECVIM-CA, Global Chief Medical Officer and Head of Medical Affairs for Zoetis. “Every medicine has potential benefits and risks, and it’s important for pet owners to work closely with their veterinarians to weigh those appropriately and maintain an open dialogue about their pets’ experiences. With nearly 25 million doses distributed globally, we stand firmly behind Librela, and the positive impact it is having on dogs that suffer from osteoarthritis pain.”

Providing Resources for Veterinarians & Pet Owners

Beginning immediately, Zoetis will make the updated U.S. Librela label and associated Client Information Sheet available on its website and share them directly with veterinarians. The updated label and Client Information Sheet will be included in future distributions of Librela.

On an ongoing basis, Zoetis provides veterinarians with many resources, including data, research and access to leading experts in the field of osteoarthritis. In the past year, Zoetis has hosted more than 1,000 medical education webinars for veterinarians to support their knowledge and understanding of how to use its products as well as held frequent Librela “office hours” with its Chief Medical Officer Dr. Goldstein to address any questions from veterinarians. At the local level, Zoetis assigns field veterinarians to regions in the markets in which it operates to provide ongoing support.

For more information about Librela, visit the Librela website here.

About Librela^® (bedinvetmab injection)

Librela is a monoclonal antibody therapy administered in the clinic that targets Nerve Growth Factor (NGF) to control canine OA pain. Librela is similar in many ways to naturally produced antibodies and is metabolized and eliminated via normal protein degradation pathways with minimal involvement of the liver or kidneys. Librela also has been approved for use in Europe, Canada, Brazil, Australia, New Zealand, Japan and other markets across South America and Asia. To learn more, please visit https://www.zoetisus.com/products/dogs/librela-a-new-era-in-treatment.

About Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After innovating ways to predict, prevent, detect, and treat animal illness for more than 70 years, Zoetis continues to stand by those raising and caring for animals worldwide – from veterinarians and pet owners to livestock producers. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $8.5 billion in 2023 with approximately 14,100 employees. For more information, visit www.zoetis.com.

IMPORTANT SAFETY INFORMATION: See full Prescribing Information. For use in dogs only. Women who are pregnant, trying to conceive or breastfeeding should take extreme care to avoid self-injection. Hypersensitivity reactions, including anaphylaxis, could potentially occur with self-injection. Librela should not be used in breeding, pregnant or lactating dogs. Librela should not be administered to dogs with known hypersensitivity to bedinvetmab. The most common adverse events reported in a clinical study were urinary tract infections, bacterial skin infections and dermatitis.

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¹ As of December 2024
² EMA Veterinary product information (QRD) templates – Annex I Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/template-form/qrd-veterinary-product-information-annotated-template-english-version-91_en.pdf. Accessed 3 February 2025

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View source version on businesswire.com: https://www.businesswire.com/news/home/20250203254176/en/

Media Contacts:

Jennifer Albano

1-862-399-0810 (o)

jennifer.albano@zoetis.com

Laura Panza

1-973-975-5176 (o)

laura.panza@zoetis.com

Investor Contacts:

Steve Frank

1-973-822-7141 (o)

steve.frank@zoetis.com

Nick Soonthornchai

1-973-443-2792 (o)

nick.soonthornchai@zoetis.com

Source: Zoetis Inc.

FAQ

What changes were made to Librela's (ZTS) U.S. label in 2024?

Zoetis updated Librela's U.S. label based on post-approval experience since its October 2023 launch, with the revised label being implemented immediately.

How many dogs have been treated with Librela (ZTS) in the United States?

More than one million dogs in the U.S. have been treated with Librela since its launch in October 2023.

What is the global safety record of Librela (ZTS)?

With nearly 25 million doses distributed globally, adverse events occur at a rate of less than 10 per 10,000 treated animals, classified as rare by European Medicines Agency standards.

When did the FDA approve Librela (ZTS) for use in the United States?

The FDA approved Librela for use in May 2023, with the product launching in the U.S. market in October 2023.