Chemistry:Bedinvetmab
Bedinvetmab, sold under the brand name Librela, is a fully canine monoclonal antibody used for the control of pain associated with osteoarthritis in dogs.[1][2][3] Librela is sponsored by Zoetis.[3][4]
Bedinvetmab was approved for medical use in the European Union in November 2020,[2] and in the United States in May 2023.[3][4] Bedinvetmab is the first monoclonal antibody approved in the United States for controlling osteoarthritis pain in dogs.[3]
Medical uses
Bedinvetmab is indicated for the alleviation of pain associated with osteoarthritis in dogs.[3][2]
Adverse effects
The most common side effects include elevated blood urea nitrogen (an indicator of kidney function), urinary tract infection, bacterial skin infection, skin irritation, rash or pain at injection site, vomiting, and weight loss.[3] The FDA issued a "Dear Veterinarian Letter" in December 2024 notifying veterinarians about adverse events reported in dogs treated with Librela (bedinvetmab injection) primarily neurological in nature, such as: ataxia, seizures, paresis, recumbency, urinary incontinence, polyuria, and polydipsia.[5]
A global pharmacovigilance reporting of the first monoclonal antibody for canine osteoarthritis in April 2025 found that the most common reported adverse events following the distribution of over 18 million doses of bedinvetmab are considered rare or very rare according to the definition by the CIOM.[6]
Pharmacology
Bedinvetmab targets nerve growth factor (NGF) which plays an important role in pain signalling in mammals and is elevated in osteroarthritic joints of dogs. The elevated NGF levels in joints lead to hyperalgesia (higher sensitivity to pain). The drug targets NGF and prevents its interaction with tropomyosin receptor kinase A (TrkA) leading to a decreased hyperalgesic response associated with osteoarthritis and has been shown effective on all three components of CBPI - pain interference, pain severity and quality of life.[7]
History
Two field studies were conducted to evaluate the effectiveness of bedinvetmab – one in the United States[8] and one in the European Union.[3] Both studies enrolled client-owned dogs diagnosed with osteoarthritis.[3] Half the dogs received bedinvetmab and half the dogs received a sterile saline injection every 28 days for a total of three doses.[3] Before treatment and on various days throughout the study, owners used the Canine Brief Pain Inventory (CBPI) assessment tool to measure the severity of the dog's pain and the degree to which the pain interfered with the dog's daily activities.[3] The weight of evidence from the two field studies demonstrated that bedinvetmab is effective at controlling pain associated with osteoarthritis in dogs when at least two doses are given 28 days apart.[3]
Society and culture
Names
Bedinvetmab is the international nonproprietary name.[9]
References
- ↑ Cite error: Invalid
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<ref>tag; no text was provided for refs namedLibrela EPAR - ↑ 3.00 3.01 3.02 3.03 3.04 3.05 3.06 3.07 3.08 3.09 3.10 "FDA Approves First Monoclonal Antibody for Dogs with Osteoarthritis Pain". 5 May 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-monoclonal-antibody-dogs-osteoarthritis-pain.
This article incorporates text from this source, which is in the public domain.
- ↑ 4.0 4.1 "Zoetis Announces U.S. FDA Approval of Librela (bedinvetmab injection) to Control Osteoarthritis (OA) Pain in Dogs" (Press release). Zoetis. 5 May 2023. Archived from the original on 6 May 2023. Retrieved 13 May 2023 – via Business Wire.
- ↑ "Dear Veterinarian Letter notifying veterinarians about adverse events reported in dogs treated with Librela (bedinvetmab injection)". U.S. Food and Drug Administration. 16 December 2024. https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-notifying-veterinarians-about-adverse-events-reported-dogs-treated-librela.
- ↑ "Global pharmacovigilance reporting of the first monoclonal antibody for canine osteoarthritis: a case study with bedinvetmab (Librela™)" (in English). Frontiers in Veterinary Science 12. 24 April 2025. doi:10.3389/fvets.2025.1558222. PMID 40343372.
- ↑ "A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a canine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis" (in en). Veterinary Anaesthesia and Analgesia 48 (6): 943–955. November 2021. doi:10.1016/j.vaa.2021.08.001. PMID 34565678.
- ↑ "Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs". Veterinary Journal (London, England) 276. October 2021. doi:10.1016/j.tvjl.2021.105733. PMID 34391918.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information 33 (3). 2019.
Further reading
- "Librela (Beransa) – Wonder Drug Or Disaster In The Making?". Dogs Naturally: 943–955. October 2023. https://www.dogsnaturallymagazine.com/librela-berensa-wonder-drug-or-disaster-in-the-making/?fbclid=IwZXh0bgNhZW0CMTAAAR0oBMBmM23KUtCfGR_rr84qVk398hR-YelvgW7zFwxQNoArC5LwofD8BcE_aem_AQB8g-ChVBdhaOAwjdz9Pc-TBsdSuv0PHlqsTiTQ4zIqjfw0TNjahjpdpy5DWradWVncyU205MK7sUb-v2S872P4.
- "Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs". Veterinary Journal (London, England) 276. October 2021. doi:10.1016/j.tvjl.2021.105733. PMID 34391918.
This article incorporates public domain material from the United States Department of Health and Human Services website https://www.fda.gov/.
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