Zoetis Receives Positive CVMP Opinion for Lenivia®, a Novel Therapy to Reduce Osteoarthritis Pain in Dogs
Zoetis Inc., a global leader in animal health, today announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Lenivia® (izenivetmab). This recommendation is specifically for the reduction of pain associated with osteoarthritis (OA) in dogs. Following the CVMP’s favorable opinion, the European Commission is expected to issue a final decision regarding approval during the fourth quarter of 2025. Zoetis anticipates that, if approved, Lenivia will become commercially available across the European Union in 2026.
Lenivia represents a significant advancement in the treatment of OA pain in dogs. It is a monoclonal antibody therapy designed to deliver long-acting pain relief for up to three months with a single injection. The therapy works by targeting nerve growth factor (NGF), a key protein involved in mediating pain and inflammation. NGF has been recognized by the scientific community as a central player in the mechanisms that drive chronic pain conditions, including osteoarthritis. By binding to NGF, Lenivia is able to modulate its activity and provide sustained relief from OA-associated discomfort, allowing dogs to regain mobility and improve overall quality of life.
The development of Lenivia is the culmination of more than a decade of research and scientific exploration into monoclonal antibody therapies for veterinary applications. Its safety and efficacy have been evaluated in extensive preclinical and clinical studies, including a nine-month field study in which dogs receiving Lenivia demonstrated meaningful improvements in mobility and a reduction in pain after a single injection. This evidence supports the potential of Lenivia to become a transformative tool in the management of OA pain for canine patients.
Understanding Osteoarthritis and Its Impact on Dogs
Osteoarthritis is a prevalent, chronic, and progressive joint disorder in dogs, marked by the gradual breakdown of joint cartilage and associated inflammation. The disease often results in significant pain, decreased mobility, and impaired quality of life for affected animals. While OA is not curable, advances in veterinary medicine have enabled interventions that can significantly reduce pain and improve the functional abilities of dogs.
Estimates suggest that nearly 40 percent of dogs, regardless of age or breed, may be affected by OA at some point in their lives. The impact of chronic pain from OA extends beyond physical discomfort; it can interfere with a dog’s movement, disrupt sleep patterns, alter behavior, and negatively affect interactions with humans and other animals. Owners may observe difficulty in climbing stairs, reluctance to exercise, or changes in temperament due to chronic discomfort. These factors highlight the importance of effective, long-lasting pain management solutions for canine OA.
“Zoetis has always been committed to understanding the unique biology of each species we serve,” said Rob Polzer, Ph.D., Executive Vice President and President of Research and Development at Zoetis. “Our approach to scientific innovation allows us to develop therapies that address unmet medical needs in animals. The CVMP’s positive opinion for Lenivia marks an important milestone in our ongoing mission to provide veterinarians with advanced options to manage osteoarthritis pain in dogs.”
Lenivia: A Long-Acting Solution for OA Pain
If approved, Lenivia will join Zoetis’ expanding portfolio of therapies designed to manage OA pain in dogs. It will complement Librela® (bedinvetmab), another monoclonal antibody targeting NGF, which has already established its place in the treatment of canine OA. While both therapies focus on NGF inhibition, Lenivia is engineered to act for a longer duration by binding to a distinct site on the NGF molecule. This allows a single injection to provide up to three months of pain relief, offering convenience for pet owners and more consistent symptom control for dogs.
“Lenivia is designed to be our first long-acting therapy that addresses OA pain in dogs, offering both enhanced mobility and quality of life for pets,” said Richard Goldstein, DVM, DACVIM, DECVIM-CA, Global Chief Medical Officer and Head of Medical Affairs at Zoetis. “For pet owners, this means fewer veterinary visits for injections while still providing their dogs with sustained relief. Four years ago, we introduced the first monoclonal antibody therapy for OA pain in Europe, and we are excited to provide veterinarians with another innovative tool to improve the lives of dogs suffering from this chronic condition.”
The potential benefits of Lenivia extend to both dogs and their owners. Chronic pain management often requires frequent veterinary visits and multiple interventions, which can be stressful for pets and demanding for owners. By providing long-lasting relief with a single injection every three months, Lenivia offers a convenient alternative that helps reduce the burden of treatment while ensuring consistent care.
Commitment to Veterinary Innovation
Zoetis continues to drive innovation in animal health through a combination of lifecycle management, geographic expansion, and disruptive technologies. The company’s robust pipeline includes therapies addressing a wide range of conditions in companion animals and livestock, reflecting its commitment to improving the health and well-being of animals worldwide. The positive CVMP opinion for Lenivia reinforces Zoetis’ position as a pioneer in monoclonal antibody therapies and highlights the company’s dedication to addressing chronic pain in dogs, a condition that affects millions of pets across Europe and beyond.
In addition to OA pain management, Zoetis’ research efforts focus on understanding the molecular mechanisms that underlie various diseases, enabling the development of targeted therapies that can provide meaningful clinical benefits. By leveraging advances in immunology, genetics, and biotechnology, Zoetis aims to deliver innovative solutions that enhance animal health while supporting the needs of veterinarians and pet owners.
“Lenivia exemplifies how sustained research and scientific insight can lead to therapies that make a tangible difference in the lives of animals,” Dr. Polzer added. “We are proud to continue our tradition of pioneering veterinary medicine and delivering options that improve the welfare of pets globally.”
The CVMP’s positive opinion for Lenivia is a critical step toward regulatory approval in the European Union. Following the EMA’s recommendation, the European Commission will review the submission and is expected to make a final decision by the fourth quarter of 2025. Upon approval, Zoetis plans to launch Lenivia in the EU in 2026, providing veterinarians and pet owners with access to a novel therapy that addresses a significant unmet need in canine osteoarthritis care.
With Lenivia, Zoetis aims not only to alleviate pain but also to improve mobility, activity levels, and overall quality of life for dogs affected by OA. The therapy represents a continuation of the company’s commitment to veterinary innovation, leveraging decades of scientific research to bring advanced, practical solutions to companion animal care.
As the veterinary community continues to seek effective, long-lasting treatments for chronic conditions like OA, Lenivia has the potential to become an important component of comprehensive pain management strategies. By combining targeted therapy with a convenient dosing schedule, Zoetis seeks to enhance both clinical outcomes for dogs and the experience of pet ownership.
In summary, Lenivia (izenivetmab) stands as a promising advancement in veterinary medicine, reflecting Zoetis’ dedication to improving the lives of animals through scientific innovation. The therapy’s potential to provide three months of pain relief with a single injection offers a meaningful improvement in OA management for dogs, aligning with Zoetis’ mission to deliver life-improving medicines and solutions for pets worldwide.
