Zoetis Inc. announced that it has updated the U.S. label for Librela^® (bedinvetmab injection), following its submission of a supplement to the U.S. Food and Drug Administration (FDA). This supplement includes updated labeling based on post-approval experience with Librela in the U.S. since the product launched over a year ago. The company remains confident in the safety and effectiveness of Librela and plans to implement the updated label immediately in its ongoing commitment to supporting veterinarians and pet owners in the use of Librela. 

Librela, a once-monthly injectable monoclonal antibody for the control of pain associated with osteoarthritis (OA) in dogs, was approved for use by the FDA in May 2023 and launched in the U.S. in October 2023. It has been used to treat more than one million dogs in the U.S.

Zoetis has been engaged with the FDA to review post-launch, real-world drug experience data reported to the agency and collected through Zoetis’ pharmacovigilance monitoring of its products’ safety and efficacy. Label updates in the pharmaceutical space are not uncommon, particularly in the first few years after a launch in response to real-world experience data.

Since its launch in Europe four years ago, Librela has improved the lives of millions of dogs suffering from OA pain. With nearly 25 million doses¹ distributed globally, no individual adverse event sign has been reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) – representing less than 10 occurrences per 10,000 treated animals (where one dose equals one treated animal)² .

“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,” said Dr. Richard Goldstein, DVM, DACVIM, DECVIM-CA, Global Chief Medical Officer and Head of Medical Affairs for Zoetis. “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.”