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 this recommendation, the European Commission is expected to issue a formal decision during the fourth quarter of 2025, with Zoetis anticipating commercial availability of Lenivia in the European Union in 2026.
If approved, Lenivia will represent a new antibody-based therapy capable of reducing OA pain in dogs for three months with a single injection. The therapy leverages novel binding properties to nerve growth factor (NGF), a protein recognized as a key mediator of pain and inflammation. Lenivia’s development draws upon over a decade of scientific research, with a safety profile supported by a nine-month field study, which demonstrated improved mobility and reduced pain in treated dogs after just one injection.
The Impact of Osteoarthritis in Dogs
Osteoarthritis is a chronic, progressive joint disease characterized by inflammation, cartilage degradation, and pain, which can significantly impact a dog’s mobility and quality of life. While the condition cannot be cured, effective pain management can substantially improve an animal’s daily functioning and overall well-being.
Epidemiological studies suggest that nearly 40% of dogs, regardless of age or size, may experience OA-related pain at some point in their lives. Chronic pain in dogs can interfere with movement, sleep, social interactions, and behavioral health, highlighting the critical need for innovative and effective treatment options.
“As the leader in animal health innovation and a pioneer in veterinary monoclonal antibodies, our scientists at Zoetis are committed to understanding each species’ unique biology,” said Rob Polzer, Ph.D., Executive Vice President and President, Research and Development at Zoetis. “The CVMP’s positive opinion for Lenivia represents a significant advancement in osteoarthritis pain management for dogs and underscores our commitment to meeting unmet medical needs in veterinary medicine.”
Lenivia: A Next-Generation Pain Management Option
Zoetis continues to expand its portfolio of advanced therapeutic solutions for companion animals through lifecycle innovation, geographic expansion, and disruptive scientific innovation. If approved, Lenivia will join Librela® (bedinvetmab) in Zoetis’ growing lineup of OA pain management therapies for dogs.
Both Lenivia and Librela are monoclonal antibodies targeting NGF, but Lenivia is designed for longer-lasting pain reduction by binding to a different site on NGF, allowing for a single injection to provide therapeutic benefits for three months. This long-acting profile is intended to enhance convenience for pet owners while supporting consistent pain relief for dogs suffering from OA.
“If approved, Lenivia will be our first long-acting therapy to manage OA pain in dogs, improving quality of life and mobility while reducing the frequency of veterinary visits,” 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 for OA pain in dogs. Lenivia builds on this foundation, providing veterinarians with an innovative new tool to support animals’ comfort and function over an extended period.”
Clinical Evidence Supporting Lenivia
Lenivia’s efficacy and safety profile is supported by extensive preclinical and clinical research. The nine-month field study evaluated dogs receiving a single injection and measured mobility, pain reduction, and quality-of-life outcomes. Results demonstrated a clinically meaningful reduction in pain alongside improvements in daily activity, supporting Lenivia as a practical and effective long-term treatment option for companion animals with OA.
The therapy’s mechanism of action, targeting NGF, addresses a critical pathway in chronic pain and inflammation, providing a scientifically validated approach to managing osteoarthritis symptoms. By modulating NGF activity, Lenivia alleviates discomfort and allows dogs to regain mobility and engage in normal behaviors, contributing to improved mental and physical well-being.
Looking Ahead: Innovation in Animal Health
Zoetis’ pursuit of transformative therapies continues to shape the landscape of veterinary care. The approval of Lenivia would reinforce the company’s leadership in monoclonal antibody therapies and further expand its offerings in OA pain management. With its long-acting design and targeted mechanism, Lenivia is expected to enhance both therapeutic outcomes for dogs and convenience for pet owners and veterinarians.
“Our commitment to understanding animal biology drives innovation,” added Dr. Polzer. “Lenivia reflects our dedication to developing therapies that make a tangible difference in the lives of pets and the people who care for them.”
As the veterinary community awaits the European Commission’s final decision, Lenivia represents a next-generation approach to managing osteoarthritis pain, promising to improve quality of life for thousands of dogs across the European Union and potentially beyond.
