Librela (bedinvetmab injection) from Zoetis was first approved by CVMP – Committee for Veterinary Medicinal Products, European Union in September 2020 and was subsequently approved by US FDA in May 2023, for the control of pain associated with osteoarthritis (OA) in dogs. Librela was the first monoclonal antibody (mAb) approved for use in dogs. This approval followed the approval of a first MAb ever, again developed by Zoetis, for usage in any animal species, a mAb for cats, which was the first mAb new animal drug approved by the FDA for the control of pain associated with OA in cats.
OA is the most common form of arthritis in dogs; it is estimated that it affects at least 25 percent of dogs at some point in their lifetime. OA is a degenerative and painful condition of the joints in which the normal cartilage cushion in the joints breaks down. OA continues to get worse over time; however, Librela, helps control the pain associated with the condition. Bedinvetmab, the active ingredient in Librela, works by binding to and inhibiting the biological activity of a protein called canine nerve growth factor (NGF), which has been found to be elevated in dogs with OA and is involved in the regulation of pain.
CVMP – Committee for Veterinary Medicinal Products,  in its recently held meeting has recommended Zoetis, the Marketing Authorization Holder of Librela, to carry out an in-depth analysis of all available information on suspected musculoskeletal disorders reported since the MAb’s marketing authorization.
Results of this analysis are expected to be submitted by the MAH by end of September 2025. CVMP recently became aware of suspected adverse events that have been reported for Librela (bedinvetmab), a medicine for the treatment of pain caused by osteoarthritis in dogs, which are not currently listed in the EU product information.Â
These suspected adverse event reports include very rare cases with the suspicion of an abnormal progress of osteoarthritis in dogs following the use of Librela. In a limited number of cases, radiographical findings have also been observed that are not usually seen in the normal progression of osteoarthritis.
The CVMP will review the information provided by the MAH, as well as all available evidence to assess the potential risk of musculoskeletal disorders in dogs treated with Librela and determine whether any change, including an update of the product information, will be needed. EMA will communicate further once the review has concluded towards the end of 2025, or sooner if new important information arises
