Zoetis Announces U.S. FDA Approval of Librela™ (bedinvetmab injection) to Control Osteoarthritis (OA) Pain in Dogs

• Librela™ is the first and only injectable monoclonal antibody (mAb) treatment for the control of canine OA pain approved in the United States
• Zoetis continues to advance innovation with a new era of pain management for dogs

Zoetis Inc. (NYSE:ZTS) today announced that the U.S. Food and Drug Administration (FDA) has approved Librela™ (bedinvetmab injection) for the control of pain associated with osteoarthritis (OA) in dogs. 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. ^1,2

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.^3,4 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.⁶ OA can affect any dog, even as young as 1 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up or down stairs, lagging behind on walks, hesitation to jump up or down, limping after exercise and becoming more withdrawn.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.⁷ Failure to treat canine OA can result in increased pain, decreased mobility and a significant impact on dogs’ overall health and well-being.⁸ 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.⁹ 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, U.S. Petcare, at Zoetis. “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.¹⁰ Additionally, in a continuation study, dogs treated with bedinvetmab experienced lasting OA pain relief over the course of the study with monthly injections.¹⁰

“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.”

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).*

Positive Clinical Experience Reported from 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.¹¹ European veterinarians who have used Librela rated their overall satisfaction 8.6 out of 10, the highest of any OA pain medication evaluated.¹² European veterinarians who have used Librela also rated Librela very highly on top product attributes for OA pain medications, including: reduces OA pain, improves mobility, and improves quality-of-life.¹²

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.¹³ 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.

IMPORTANT SAFETY INFORMATION ABOUT LIBRELA™

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 dogs or in 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.

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.

DISCLOSURE NOTICES

Forward-Looking Statements: This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to business plans or prospects, expectations regarding products, including timing of shipments, 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.

*For the vast majority of dogs, an increase in BUN was not associated with clinical signs or changes in other renal parameters.

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¹ Brown DC, Boston RC, Coyne JC, Farrar JT. Development and psychometric testing of an instrument designed to measure chronic pain in dogs with osteoarthritis. Am J Vet Res. 2007;68(6):631-637. doi:10.2460/ajvr.68.6.631.

² Brown DC, Boston RC, Coyne JC, Farrar JT. Ability of the Canine Brief Pain Inventory to detect response to treatment in dogs with osteoarthritis. J Am Vet Med Assoc. 2008;233(8):1278-1283. doi:10.2460/javma.233.8.1278.

³ IHS Markit. (2021) Canine and Feline Pain Market 2021: Animal Health Market Analysis.

⁴ Wright A, et al. Identification of canine osteoarthritis using an owner-reported questionnaire and treatment monitoring using functional mobility tests. J Small Anim Pract, 2022. http://doi.org/10.1111/jsap.13500

⁵ AVMA: U.S. Pet Ownership & Demographics Sourcebook, 2022

⁶ Anderson KL, Zulch H, O’Neill DG, Meeson RL, Collins LM. Risk factors for canine osteoarthritis and its predisposing arthropathies: a systematic review. Front Vet Sci. 2020;7:200. doi:10.3389/fvets.2020.00220

⁷R: PetTrak US Pain Factored National January 2023.

⁸ Lascelles BDX, et al. Measurement of chronic pain in companion animals: discussions from the Pain in Animals Workshop (PAW) 2017. Vet J. 2019;250(8):71-78.

⁹ Enomoto M, et al. Anti-nerve growth factor monoclonal antibodies for the control of pain in dogs and cats. Veterinary Record. 2018. doi: 10.1136/vr.104590.

¹⁰ Corral, MJ, et al. A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a canine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis. Vet Anaesth Analg. 2021;48:943-955.

¹¹ Data on File. November 2022.

¹² ZMR: Librela Post Launch Tracker Wave 3 UK/Germany/France/Spain/Italy 2022

¹³ Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49(8):493-507.

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