01/13/2025
Update on Librela received from the Chief Medical Officer at the manufacturer, Zoetis
2025-January-07
Dear Dr. Weiner,
I’m reaching out to share an update about Librela® (bedinvetmab injection). On Monday, December 16, the FDA issued an update on the CVM website, which includes a summary and a standard agency review of adverse events reported since Librela’s U.S. launch. 1
Zoetis remains confident in the safety and efficacy profile of Librela, and how it is helping dogs experiencing osteoarthritis (OA) pain. Veterinarian satisfaction with the product remains high and reflects their experience treating patients with Librela.
Since March the FDA has provided three Freedom of Information Act (FOIA) reports with updates on Librela’s reported adverse events in the U.S.2 These updates are provided based on third-party requests that are made to the agency, but ultimately provide public information on what data is being reported. The information shared by the FDA is consistent with what we’ve seen in our pharmacovigilance data and what has been shared previously by the FDA in FOIA reports. As always, we ask for your help in reporting all adverse events to Zoetis as there are regulatory obligations to report to the FDA.
To build upon the information in the FDA update, we’d like to share the following directly with you:
• Librela has undergone robust testing and has been approved as safe and effective for controlling osteoarthritis pain in dogs.
• Within the FDA Standard Adverse Event Review, there is a more detailed analysis which gives context to Librela and all of the cases reported in dogs including age distribution, and a comparison of adverse events reported with use of other OA related products.
• Zoetis is in discussions with the FDA on label updates and expects it will reflect post approval adverse event reporting and be similar to labels in other markets.
• With more than 21 million doses distributed globally, no individual adverse event sign is reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) as
