Zoetis Receives Positive Opinion from CVMP for Lenivia® (izenivetmab) to Reduce Pain Associated with Osteoarthritis (OA) in Dogs
Zoetis Inc. today announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for Lenivia® (izenivetmab) for the reduction of pain associated with osteoarthritis (OA) in dogs. Based on the CVMP's positive opinion, the European Commission is expected to issue a decision during the fourth quarter of 2025, and Zoetis anticipates making Lenivia commercially available in the European Union in 2026.
If approved, Lenivia will be a new antibody therapy that reduces OA pain in dogs for three months with one injection through its novel binding properties to nerve growth factor (NGF), recognized as an important mediator of pain and inflammation. Lenivia is built on a decade of science and research, with a safety profile demonstrated in a nine-month field study where dogs receiving Lenivia experienced increased mobility and decreased pain after one injection.
Significance of OA Pain
Osteoarthritis is a common, chronic and progressive joint disease characterized by the inflammation and breakdown of joints, resulting in pain and mobility issues. Although the disease cannot be cured, much can be done to reduce the associated pain, leading to improved quality of life. Nearly 40 percent of dogs of any age or size may be affected by OA pain1, 2, and chronic pain can negatively impact dogs' movement, sleep, behavior and social relationships3.
"As the leader in animal health innovation and the groundbreaker in veterinary monoclonal antibodies, our scientists at Zoetis are committed to deeply understanding each unique species' biology, which drives the discovery and development that ultimately helps us meet our customers' unmet medical needs," said Rob Polzer, Ph.D., Executive Vice President and President, Research and Development at Zoetis. "The CVMP's positive opinion for Lenivia represents another advancement in OA pain management for dogs."
Continued Innovation to Meet Medical Needs
Zoetis continues to advance care for animals around the globe with a robust pipeline fueled by lifecycle innovation, geographic expansion and disruptive innovation. If approved, Lenivia will join Librela® (bedinvetmab) in the company's growing portfolio of OA pain products for dogs. Like Librela, Lenivia is a monoclonal antibody that targets NGF; however, Lenivia is designed to reduce pain associated with OA for a longer period of time by binding to a different site on NGF.
"If approved, Lenivia will be our first long-acting therapy that reduces OA pain in dogs, leading to improved quality of life and mobility. It also provides added convenience for pet owners who want to bring their dogs in for an injection just once every three months," said Richard Goldstein, DVM, DACVIM, DECVIM-CA, Global Chief Medical Officer and Head of Medical Affairs at Zoetis. "Four years ago in Europe, we introduced the first monoclonal antibody therapy designed to manage pain associated with OA in dogs, and we look forward to providing veterinarians with another innovative tool to help them manage pain associated with OA for the animals in their care."
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 $9.3 billion in 2024 with approximately 13,800 employees. For more information, visit www.zoetis.com.
DISCLOSURE NOTICES
Forward-Looking Statements: This press release contains forward-looking statements which reflect the current views of Zoetis with respect to: our business plans or prospects; expectations regarding products, product approvals or licenses, products under development; and other future events. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management's underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our most recent Annual Report on Form 10-K, including in the sections thereof captioned "Forward-Looking Statements and Factors That May Affect Future Results" and "Item 1A. Risk Factors," in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.
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1Wright A, Amodie DM, Cernicchiaro N, et al. Identification of canine osteoarthritis using an owner-reported questionnaire and treatment monitoring using functional mobility tests. J Small Anim Pract. 2022;63(8):609-618.
2Enomoto M, de Castro N, Hash J, et al. Prevalence of radiographic appendicular osteoarthritis and associated clinical signs in young dogs. Sci Rep. 2024;14(1):2827.
3Lascelles BDX, Brown DC, Conzemius MG, Gill M, Oshinsky ML, Sharkey ML. Measurement of chronic pain in companion animals: discussions from the Pain in Animals Workshop (PAW) 2017. Vet J. 2019;250:71-78.
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