FDA approves first monoclonal antibody for managing OA pain in dogs

Officials with the FDA have approved bedinvetmab injection (Librela; Zoetis) for the control of pain associated with osteoarthritis (OA) in dogs. This prescription drug is the first monoclonal antibody (mAb) the FDA has approved for use in dogs.^1,2

OA is the most common form of arthritis in dogs and is estimated to affect at least 25% of dogs at some point in their lifetime, according to the FDA.¹ The condition affects dogs of all ages, sizes, and breeds, including those as young as 1 year.²

“The FDA approval of Librela represents a significant step forward in our ability to provide comfort to dogs living with the chronic pain associated with OA, ultimately strengthening the unbreakable bond people share with their pets,” said Laura Olsen, senior vice president, US Petcare, at Zoetis, in an organizational release.²

The pain of OA can impact a dog’s physical and emotional health, according to Zoetis. Signs of OA include, but are not limited to, difficulty in going up or down stairs, lagging behind on walks, hesitation to jump up or down, limping after exercise and becoming more withdrawn.²

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. Bedinvetmab injection can help control the pain associated with the condition by working to bind to and inhibit the biological activity of the canine nerve growth factor (NGF) protein. NGF 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, according to the FDA.¹

Failure to treat canine OA can result in increased pain, decreased mobility and a significant impact on dogs’ overall health and well-being, according to Zoetis. “Pain is often overlooked in dogs for 2 primary reasons: the signs of OA pain are misinterpreted as normal aging and OA pain is not considered in younger dogs,” said Duncan Lascelles, BSc, BVSc, PhD, professor of translational research in pain and surgery at North Carolina State University in Raleigh, in the release.² “As our understanding of canine pain expands, [bedinvetmab injection] provides a unique monthly treatment to control OA pain in dogs by targeting NGF, helping to improve their comfort, mobility and overall well-being.”

Bedinvetmab injection 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. It is administered by subcutaneous injection once a month and dosed by weight range to target a minimum dose of 0.5 mg/kg.¹ With once-monthly injections administered by a veterinary professional, bedinvetmab injection may also reduce pet owner stress about missing a daily treatment dose and help maintain the human-animal bond.²

Two field studies were conducted to evaluate the effectiveness of bedinvetmab injection–1 in the United States and 1 in the European Union. Both studies enrolled client-owned dogs diagnosed with OA. Half the dogs received bedinvetmab injection and half the dogs received a sterile saline injection every 28 days for a total of 3 doses. Before treatment and on various days throughout the study, owners used the Canine Brief Pain Inventory 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 2 field studies demonstrated that bedinvetmab injection is effective at controlling pain associated with OA in dogs when at least 2 doses are given 28 days apart.^1,2

The most common adverse effects seen in dogs treated with bedinvetmab injection included increased 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. Veterinarians should advise owners about the possible adverse events and effects before using the drug.

Librela was granted marketing authorization by the European Medicines Agency in 2020 and the product was launched in 2021. It is expected to be made available in the US in 2023.²

References

1. FDA approves first monoclonal antibody for dogs with osteoarthritis pain. News release. FDA. May 5, 2023. Accessed May 5, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-monoclonal-antibody-dogs-osteoarthritis-pain?utm_medium=email&utm_source=govdelivery
2. Zoetis Announces U.S. FDA Approval of Librela™ (bedinvetmab injection) to Control Osteoarthritis (OA) Pain in Dogs. News release. Zoetis. May 5, 2023. Accessed May 5, 2023. https://investor.zoetis.com/news/news-details/2023/Zoetis-Announces-U.S.-FDA-Approval-of-Librela-bedinvetmab-injection-to-Control-Osteoarthritis-OA-Pain-in-Dogs/default.aspx