Bedinvetmab

Bedinvetmab, sold under the brand name Librela is a canine monoclonal antibody used for the control of pain associated with osteoarthritis in dogs. Librela is sponsored by Zoetis.

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).

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

Side effects reported in the EUDRA-Vigilance Database of over 16,000 cases include:


 * 1) Systemic Disorders (including death)
 * 2) Neurological Disorders
 * 3) Renal and Urinary Disorders
 * 4) Digestive Track Disorders
 * 5) Musculoskeletal
 * 6) Respiratory Disorders
 * 7) Ear and Labrinth Disorders
 * 8) Cardio-vascular system disorders
 * 9) Eye Disorders
 * 10) Hipato-Biliary Disorders

Medical uses
Bedinvetmab is indicated for the alleviation of pain associated with osteoarthritis in dogs.

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

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).

Names
Bedinvetmab is the international nonproprietary name.