Bedinvetmab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Target | Nerve growth factor (NGF) |
| Clinical data | |
| Trade names | Librela |
| License data |
|
| Routes of administration | Subcutaneous |
| ATCvet code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| UNII | |
Bedinvetmab, sold under the brand name Librela is a canine monoclonal antibody used for the control of pain associated with osteoarthritis in dogs.[3][4][6] Librela is sponsored by Zoetis.[6][5]
The most common side effects include increased blood urea nitrogen (an indicator of kidney function), urinary tract infection, bacterial skin infection, skin irritation (dermatitis), rash (erythema) or pain at injection site, vomiting (emesis), and weight loss (anorexia).[6]
Bedinvetmab was approved for medical use in the European Union in November 2020,[4] and in the United States in May 2023.[6][5] Bedinvetmab is the first monoclonal antibody approved in the United States for controlling osteoarthritis pain in dogs.[6]
Side effects reported in the EUDRA-Vigilance Database of over 16,000 cases include:
- Systemic Disorders (including death)
- Neurological Disorders
- Renal and Urinary Disorders
- Digestive Track Disorders
- Musculoskeletal
- Respiratory Disorders
- Ear and Labrinth Disorders
- Cardio-vascular system disorders
- Eye Disorders
- Hipato-Biliary Disorders
Medical uses
Bedinvetmab is indicated for the alleviation of pain associated with osteoarthritis in dogs.[6][4]
History
Two field studies were conducted to evaluate the effectiveness of bedinvetmab – one in the United States[7] and one in the European Union.[6] Both studies enrolled client-owned dogs diagnosed with osteoarthritis.[6] Half the dogs received bedinvetmab and half the dogs received a sterile saline injection every 28 days for a total of three doses.[6] 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.[6] 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.[6]
On November 20, 2023, the United States Food and Drug Administration Center for Veterinary Medicine (US FDA CVM) issued an Untitled Letter to Zoetis for making false or misleading claims and representations about the efficacy of bedinvetmab (Librela).[8]
Society and culture
Names
Bedinvetmab is the international nonproprietary name.[9]
References
- ^ "LIBRELA Product information". Health Canada.
- ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
- ^ a b "Librela (bedinvetmab injection) Injectable Solution Dogs". Zoetis Inc. U.S. Food and Drug Administration. NADA 141-562.
- ^ a b c d "Librela EPAR". European Medicines Agency (EMA). 21 February 2022. Archived from the original on 16 March 2023. Retrieved 13 May 2023.
- ^ a b c "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.
- ^ a b c d e f g h i j k "FDA Approves First Monoclonal Antibody for Dogs with Osteoarthritis Pain". U.S. Food and Drug Administration (FDA). 5 May 2023. Retrieved 13 May 2023.
This article incorporates text from this source, which is in the public domain.
- ^ Krautmann M, Walters R, Cole P, Tena J, Bergeron LM, Messamore J, et al. (October 2021). "Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs". Veterinary Journal. 276: 105733. doi:10.1016/j.tvjl.2021.105733. PMID 34391918.
- ^ "US FDA CVM November 20, 2023 Untitled Letter to Zoetis re: NADA 141-562". US Food and Drug Administration.
- ^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.
Further reading
- Bassingthwaighte E (October 2023). "Librela (Beransa) – Wonder Drug Or Disaster In The Making?". Dogs Naturally: 943–955.
- Krautmann M, Walters R, Cole P, Tena J, Bergeron LM, Messamore J, et al. (October 2021). "Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs". Veterinary Journal. 276: 105733. 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
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