Zoetis announces FDA approval of Librela to control osteoarthritis pain in dogs
Zoetis Inc. announced on May 5 that the U.S. Food and Drug Administration (FDA) approved Librela™ (bedinvetmab injection) for the control of pain associated with osteoarthritis (OA) in dogs. According to a news release, Librela is the first and only once-monthly, anti-NGF monoclonal antibody treatment for canine OA pain and is approved as safe and effective in providing long-term control of OA pain symptoms in dogs, which can improve their mobility and overall quality of life.
The unmet need in canine OA
Canine OA is a painful and progressive disease that is highly prevalent. In studies, 40% of dogs have signs of OA. With an estimated 86 million dogs living in the U.S. households, a high percentage of dogs are likely experiencing OA pain.5 OA does not only impact older dogs – it affects dogs of all ages, sizes, and breeds. OA can affect any dog, even as young as a one-year-old.
The pain of OA can impact a dog’s physical and emotional health. Signs of OA include, but are not limited to, difficulty in going up or down stairs, lagging behind on walks, hesitation to jump up or down, limping after exercise and becoming more withdrawn.
Despite the prevalence of OA pain in dogs in the U.S., only 33% with OA are actively being treated. Failure to treat canine OA can result in increased pain, decreased mobility and a significant impact on dogs’ overall health and well-being. Current treatment choices have limitations, including lack of effectiveness, difficulty in administration and safety concerns, which contribute to the overall low treatment rate for OA pain. With once-monthly injections administered by a veterinary professional, Librela may also reduce pet owner stress about missing a daily treatment dose and help maintain the human-animal bond.
“Zoetis has a 25-year legacy in pain management and has revolutionized how the veterinary industry approaches this critical area of pet care,” said Laura Olsen, senior vice president at Zoetis in the news release. “The FDA approval of Librela represents a significant step forward in our ability to provide comfort to dogs living with the chronic pain associated with OA, ultimately strengthening the unbreakable bond people share with their pets.”
Clinical trial results
Librela represents a new era in pain management as the first monoclonal antibody approved in the U.S to control OA pain in dogs. This once monthly injection works differently from other pain medications – it’s unique mode of action targets Nerve Growth Factor (NGF), a key component of OA pain.
In two field studies, dogs administered Librela as a monthly injection demonstrated a reduction in OA pain compared to dogs that received the placebo and by reducing pain, Librela was shown to help their mobility and overall quality of life.10 While effectiveness may not be seen until after the second dose of Librela, some dogs may experience a reduction in pain as early as seven days after the first dose. Additionally, in a continuation study, dogs treated with bedinvetmab experienced lasting OA pain relief over the course of the study with monthly injections.
“Pain is often overlooked in dogs for two primary reasons: the signs of OA pain are misinterpreted as normal aging and OA pain is not considered in younger dogs,” said Dr. Duncan Lascelles, professor of Translational Research in Pain and Surgery at North Carolina State University and recent past chair of the WSAVA Global Pain Council. “As our understanding of canine pain expands, Librela provides a unique monthly treatment to control OA pain in dogs by targeting NGF, helping to improve their comfort, mobility and overall well-being.”
At the VMX in January 2023, Lascelles explained at a press briefing that nerve growth factor is a protein.
“In a developing fetus in the early neonatal period, it’s critical for normal development of sensory system,” he said. But in the adult phase of life, nerve growth factor can be over-expressed. When that occurs, sensory nerves become hyper-responsive. Nerve growth factor subsequently plays a role in initiating, driving and maintaining pain.
“Luckily for us as clinicians, we have various pharmaco-therapeutic approaches,” he said at the VMX during a session that highlighted FDA approval of Solensia, the first treatment for the control of pain associated with osteoarthritis in cats.
The most developed approach is the use of monoclonal antibodies, which bind to the nerve growth factor and prevent it from interacting with the receptor. Monoclonal antibodies have been used successfully in humans for years. This therapeutic also became more well-known at the start of the pandemic to treat COVID-19 in people who tested positive for the virus.
Adverse events were similar to what would be expected for this population of dogs with OA. The most common adverse events reported in dogs treated with Librela included urinary tract infections, bacterial skin infections, dermatitis and increased blood urea nitrogen (BUN). For the vast majority of dogs, an increase in BUN was not associated with clinical signs or changes in other renal parameters.
Positive clinical experience reported by European veterinarians
Librela was granted marketing authorization by the European Medicines Agency (EMA) in 2020 and the product was launched in 2021. Librela has been used by veterinarians in Europe for more than two years as a treatment option for OA pain in dogs with over 4.6 million doses distributed. European veterinarians who have used Librela rated their overall satisfaction 8.6 out of 10, the highest of any OA pain medication evaluated. European veterinarians who have used the product also rated Librela highly on top product attributes for OA pain medications, including reduces OA pain, improves mobility, and improves quality-of-life.
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 functions like 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 Canada, Brazil, Australia, New Zealand, Japan and other markets across South America and Asia. Librela is expected to be available to veterinarians in the U.S. in late 2023. To learn more, please visit zoetisus.com/products/dogs/librela.
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 farmers and ranchers. 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 $8.1 billion in 2022 with approximately 13,800 employees. For more information, visit www.zoetis.com.
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