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Bedinvetmab

From Wikipedia, the free encyclopedia
Monoclonal antibody

Pharmaceutical compound
Bedinvetmab
Monoclonal antibody
TypeWhole antibody
TargetNerve growth factor (NGF)
Clinical data
Trade namesLibrela
AHFS/Drugs.comVeterinary Use
License data
Routes of
administration
Subcutaneous
ATCvet code
Legal status
Legal status
Identifiers
CAS Number
UNII

Bedinvetmab, sold under the brand nameLibrela, is a fully caninemonoclonal antibody used for the control of pain associated withosteoarthritis in dogs.[3][4][5] Librela is sponsored by Zoetis.[5][6]

Bedinvetmab was approved for medical use in the European Union in November 2020,[4] and in the United States in May 2023.[5][6] Bedinvetmab is the first monoclonal antibody approved in the United States for controlling osteoarthritis pain in dogs.[5]

Medical uses

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Bedinvetmab isindicated for the alleviation of pain associated with osteoarthritis in dogs.[5][4]

Adverse effects

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The most common side effects include elevatedblood urea nitrogen (an indicator of kidney function),urinary tract infection,bacterial skin infection,skin irritation,rash orpain at injection site,vomiting, andweight loss.[5] TheFDA 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, andpolydipsia.[7]

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.[8]

Pharmacology

[edit]

Bedinvetmab targetsnerve 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 tohyperalgesia (higher sensitivity to pain). The drug targets NGF and prevents its interaction withtropomyosin 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.[9]

History

[edit]

Two field studies were conducted to evaluate the effectiveness of bedinvetmab – one in the United States[10] and one in the European Union.[5] Both studies enrolled client-owned dogs diagnosed with osteoarthritis.[5] Half the dogs received bedinvetmab and half the dogs received a sterile saline injection every 28 days for a total of three doses.[5] 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.[5] 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.[5]

Society and culture

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Names

[edit]

Bedinvetmab is the international nonproprietary name.[11]

References

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  1. ^"Librela Product information".Health Canada.
  2. ^"Health product highlights 2021: Annexes of products approved in 2021".Health Canada. 3 August 2022. Retrieved25 March 2024.
  3. ^ab"Librela (bedinvetmab injection) Injectable Solution Dogs".Zoetis Inc. U.S. Food and Drug Administration. NADA 141-562.
  4. ^abcd"Librela EPAR".European Medicines Agency (EMA). 21 February 2022.Archived from the original on 16 March 2023. Retrieved13 May 2023.
  5. ^abcdefghijk"FDA Approves First Monoclonal Antibody for Dogs with Osteoarthritis Pain".U.S.Food and Drug Administration (FDA). 5 May 2023. Archived fromthe original on 13 May 2023. Retrieved13 May 2023.Public Domain This article incorporates text from this source, which is in thepublic domain.
  6. ^ab"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. Retrieved13 May 2023 – via Business Wire.
  7. ^"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. Archived from the original on 16 December 2024. Retrieved29 May 2025.{{cite web}}: CS1 maint: bot: original URL status unknown (link)
  8. ^Monteiro BP, Simon A, Knesl O, Mandello K, Nederveld S, Olby NJ, et al. (24 April 2025)."Global pharmacovigilance reporting of the first monoclonal antibody for canine osteoarthritis: a case study with bedinvetmab (Librela™)".Frontiers in Veterinary Science.12 1558222.doi:10.3389/fvets.2025.1558222.PMC 12061024.PMID 40343372.
  9. ^Moyaert H, Fernandes T, Escalada M, Kira S, Tena J, Walters RR, et al. (November 2021)."A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a canine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis".Veterinary Anaesthesia and Analgesia.48 (6):943–955.doi:10.1016/j.vaa.2021.08.001.PMID 34565678.
  10. ^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. London, England.doi:10.1016/j.tvjl.2021.105733.PMID 34391918.
  11. ^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

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Public Domain This article incorporatespublic domain material from the United States Department of Health and Human Services

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