Zoetis announced the U.S. commercial launch of Librela™(bedinvetmab injection), further demonstrating the company’s advanced leadership in canine innovation and dedication to providing individualized care to address the health needs of dogs. Librela was approved by the U.S. Food and Drug Administration (FDA) on May 5, 2023 as a once-monthly injectable monoclonal antibody for the control of pain associated with osteoarthritis (OA) in dogs, helping to improve the mobility and quality of life for dogs with OA pain.[i],[ii]
“As a recognized leader in canine health care, Zoetis is committed to continually exploring opportunities to advance the treatment landscape for dogs,” said Ester Banque, Executive Vice President and President, U.S. Operations at Zoetis. “With Librela, veterinarians now have access to an innovative therapy that may improve treatment compliance and quality of life for beloved pets. OA pain is a prevalent condition in many dogs, and we look forward to working with veterinarians to positively impact the health and wellbeing of dogs and further strengthen the bond pet owners share with their dogs.”
Addressing Unmet Needs in Canine OA Pain
Canine OA is a painful and progressive disease that is highly prevalent. In studies, nearly 40% of dogs had signs of OA.[iii],[iv] With an estimated 86 million dogs living in U.S. households, a high percentage of dogs are likely experiencing OA pain.[v] OA does not just come with old age – it affects dogs of all ages, sizes and breeds.[vi] OA can affect any dog, even as young as 1 year old. The pain of OA can impact your 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up or down stairs, lagging behind on walks, hesitation to jump up or down, limping after exercise and becoming more withdrawn.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., less than half are diagnosed because dog owners often overlook the signs of OA, attributing them to normal aging.[vii] Failure to treat canine OA can result in increased pain, decreased mobility and have a negative impact on dogs’ overall health and well-being.[viii]
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.[ix] With once-monthly injections administered by a veterinary professional, Librela may also reduce pet owner stress about missing an oral, daily treatment dose and help maintain the human-animal bond.
Supporting the Human-Animal Bond With Continued Innovation in Canine Dermatology
Zoetis also recently launched Apoquel® Chewable (oclacitinib chewable tablet) in the U.S. for the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Pruritus is the most common sign of allergies in dogs, and allergic dermatitis (environmental allergies) affects up to 15% of the dog population.[x]
With Apoquel Chewable, pet owners will have a new treatment option to help improve medication compliance while helping to maintain the human-animal bond by making daily dosing less stressful.
“When it comes to addressing common health issues in canines, our approach is to understand our customers’ unmet needs and apply our scientific expertise to develop the best solution,” said Robert J. Polzer, PhD, Executive Vice President and President, Research & Development, at Zoetis. “We are committed to exploring new treatment modalities and formulations that reflect the real-world needs of pet owners. Innovations like Librela and Apoquel Chewable give veterinarians the flexibility to provide individualized treatment for the dogs in their care, which can result in better outcomes for these beloved animals.”
Both Librela and Apoquel Chewable represent first and only treatment formulations in their respective categories and offer additional treatment options for individualized health care for dogs that not only meets their medical treatment needs, but also supports the specific and diverse lifestyle needs of pet owners across the country.
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.[xi] 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 zoetisus.com/products/dogs/librela.
Librela™ Important Safety Information
See full Prescribing Information at LibrelaPI.com. 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.
Apoquel® Important Safety Information
Do not use Apoquel or Apoquel Chewable in dogs less than 12 months of age or those with serious infections. Apoquel and Apoquel Chewable may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. Apoquel and Apoquel Chewable have not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. Apoquel and Apoquel Chewable have been used safely with many common medications including parasiticides, antibiotics and vaccines. See full Prescribing Information for Apoquel and Apoquel Chewable.
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.