OA Pain Zoetis Updates U.S. Label for Librela® to Enhance Support for Veterinarians and Pet Owners
OA Pain Zoetis a global leader in animal health, has announced a key update to the U.S. label for Librela® (bedinvetmab injection). This change follows OA Pain Zoetis’ submission of a supplement to the U.S. Food and Drug Administration (FDA), incorporating real-world post-approval data collected since Librela was introduced in the U.S. over a year ago. The company remains steadfast in its confidence regarding Librela’s safety and efficacy and is committed to ensuring that veterinarians and pet owners have the latest information for optimal use of this groundbreaking treatment. The revised label will be implemented immediately and made available through OA Pain Zoetis’ official channels.
Librela: A Breakthrough Treatment for Canine Osteoarthritis Pain
Librela is a once-monthly injectable monoclonal antibody treatment designed to manage osteoarthritis (OA) pain in dogs. Since its U.S. FDA approval in May 2023 and subsequent launch in October 2023, it has rapidly gained traction among veterinarians and pet owners, improving the quality of life for over one million dogs nationwide. The monoclonal antibody technology in Librela provides targeted pain relief by inhibiting nerve growth factor (NGF), a key player in OA pain, thus reducing inflammation and discomfort in affected dogs.
Understanding the Label Update Process
As part of the ongoing commitment to veterinary medicine and animal health, Zoetis actively collaborates with regulatory bodies like the FDA to assess post-market data. This proactive approach ensures that the latest safety and efficacy information is reflected in product labeling. While updates to pharmaceutical labels are routine, particularly in the early years following a product’s launch, they are crucial in providing healthcare professionals and pet owners with the most accurate and comprehensive information about a medication’s use, potential benefits, and associated risks.
Global Success and Real-World Data Insights
Since Librela’s initial launch in Europe four years ago, it has demonstrated remarkable effectiveness, significantly improving the lives of millions of dogs suffering from OA pain. With nearly 25 million doses distributed globally, Librela has maintained a strong safety profile. According to the European Medicines Agency (EMA), no single adverse event sign has been reported at a rate higher than “rare,” meaning fewer than 10 occurrences per 10,000 treated animals. This data underscores Librela’s reliability and its transformative impact on canine OA management.
Dr. Richard Goldstein, DVM, DACVIM, DECVIM-CA, Global Chief Medical Officer and Head of Medical Affairs for Zoetis, emphasized the company’s commitment to transparency and safety:
“Pets are at the center of everything we do at Zoetis, and we are constantly working to support veterinarians and pet parents in ensuring they have the resources to make informed decisions for the animals in their care. Every medicine has potential benefits and risks, and it’s important for pet owners to work closely with their veterinarians to weigh those appropriately and maintain an open dialogue about their pets’ experiences. With nearly 25 million doses distributed globally, we stand firmly behind Librela, and the positive impact it is having on dogs that suffer from osteoarthritis pain.”
What the Label Update Means for Veterinarians and Pet Owners
Effective immediately, Zoetis is making the updated U.S. Librela label available through its website and distributing copies directly to veterinarians. The update will also be included in all future shipments of Librela, ensuring that veterinary professionals receive the most up-to-date information when prescribing this treatment to their patients.
The label update includes:
- New insights based on post-market surveillance data.
- Additional details about potential adverse reactions, based on real-world use.
- Enhanced guidance on dosage, administration, and monitoring for optimal outcomes.
By refining the label with real-world data, Zoetis aims to equip veterinarians with comprehensive knowledge, enabling them to offer more informed recommendations and closely monitor their canine patients’ response to treatment.
Educational Resources and Ongoing Support
In addition to updating Librela’s labeling, Zoetis continues to provide extensive educational resources to veterinarians. Over the past year, the company has hosted more than 1,000 medical education webinars, facilitating in-depth discussions about Librela and its role in managing OA pain in dogs. These sessions feature leading experts in veterinary medicine, offering insights into best practices, case studies, and emerging research.
Moreover, Zoetis regularly conducts Librela “office hours” with Dr. Goldstein, providing veterinarians with opportunities to ask questions and receive direct guidance from the company’s top medical professionals. This hands-on support ensures that veterinarians remain well-equipped to maximize the benefits of Librela for their patients.
On a regional level, Zoetis assigns dedicated field veterinarians to various markets, offering on-the-ground expertise and personalized support. These professionals play a crucial role in educating veterinary clinics about Librela’s benefits, addressing any concerns, and reinforcing the company’s commitment to improving animal health.
The Future of Osteoarthritis Treatment in Dogs
Osteoarthritis is a common yet debilitating condition in dogs, particularly as they age. Traditionally, treatment options have included nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, and lifestyle modifications. While these approaches can be effective, they often come with limitations, including potential side effects and inconsistent pain relief.
Librela represents a major advancement in OA treatment, offering a biologic approach that specifically targets NGF, providing long-lasting relief with minimal systemic impact. Unlike NSAIDs, Librela is not metabolized through the liver or kidneys, making it a safer option for dogs with underlying health conditions that may preclude the use of traditional pain management medications.
The success of Librela underscores a growing trend in veterinary medicine: the adoption of monoclonal antibodies for treating chronic conditions in companion animals. As research continues to evolve, similar therapies may emerge for other diseases, expanding the options available for veterinary care.
