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          FDA Approves First Monoclonal Antibody for Dogs with Osteoarthritis PainCVM Updates FDA Approves First Monoclonal Antibody for Dogs with Osteoarthritis Pain
  
  	
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Today, the U.S. Food and Drug Administration approved Librela (bedinvetmab injection) for the control of pain associated with osteoarthritis (OA) in dogs. Librela is the first monoclonal antibody (mAb) the FDA has approved for use in dogs. The FDA approved a mAb for cats on January 13, 2022, which was the first mAb new animal drug approved by the FDA for use in any animal species and the first treatment 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. Eventually, the bones in the joint rub against each other, causing pain, decreased joint movement, and sometimes formation of bone spurs or other changes in and around the joint. OA continues to get worse over time; however, Librela can help 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. When bedinvetmab binds to NGF, it prevents the pain signal from reaching the brain.

Two field studies were conducted to evaluate the effectiveness of Librela – one in the United States and one in the European Union. Both studies enrolled client-owned dogs diagnosed with OA. Half the dogs received Librela 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 Librela is effective at controlling pain associated with OA in dogs when at least two doses are given 28 days apart.

Librela is only available by prescription from a licensed veterinarian because professional expertise is required to properly diagnose pain associated with OA in dogs, administer the injection, and monitor the safe use of the product, including treatment of any adverse reactions. Librela is given by subcutaneous injection once a month and dosed by weight range to target a minimum dose of 0.5 mg/kg.

The most common side effects seen in dogs treated with Librela included 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).

Veterinarians should advise owners about the possible adverse events and side effects before using the drug. The FDA encourages dog owners to work with their veterinarian to report any adverse events or side effects potentially related to the use of any drug, including Librela.

Librela injectable solution is supplied as a sterile buffered solution of 5, 10, 15, 20 and 30 mg bedinvetmab/mL in single-use vials containing an extractable volume of 1 mL of clear solution.

Librela is sponsored by Zoetis, based in Kalamazoo, Michigan.

For more information:

Freedom of Information Summary**Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.**

                                                                                  Content current as of:
      05/05/2023CVM Updates
 
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