FDA Approves First Monoclonal Antibody to Manage Osteoarthritis Pain in Dogs

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FDA officials 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) that the FDA has approved for use in dogs.1.2

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

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

Pain from osteoarthritis can impact a dog’s physical and emotional health, according to Zoetis. Signs of osteoarthritis include, but are not limited to, difficulty going up or down stairs, delay in taking steps, hesitance to jump up and down, limping after exercise, and withdrawing.2

Osteoarthritis is a degenerative and painful joint disease in which the normal cartilage cushion of the joints breaks down. Eventually, the bones in the joint rub against each other, causing pain, decreased joint movement, and sometimes the formation of bone spurs or other changes in and around the joint. Osteoarthritis continues to get worse over time. Bedinvetmab injection may help control pain associated with the disease by working to bind to the canine nerve growth factor (NGF) protein and inhibit its biological activity. NGF has been shown to be elevated in dogs with osteoarthritis and is involved in pain regulation. When bedinvetmab binds to NGF, it blocks the pain signal from reaching the brain, according to the FDA.1

According to Zoetis, failure to treat canine osteoarthritis can lead to increased pain, decreased mobility, and a significant impact on dogs’ overall health and well-being. “Pain is often overlooked in dogs for 2 main reasons: signs of osteoarthritic pain are misinterpreted as normal aging and osteoarthritic pain is not recognized in young dogs,” said Duncan Lascelles, BSc , BVSc, PhD, professor of translational pain research and surgery at North Carolina State University in Raleigh, in the release.2 “As our understanding of canine pain expands, (bedinvetmab injection) provides a single monthly treatment to control osteoarthritic pain in dogs by targeting NGF, helping to improve their comfort, mobility and mobility. general well-being.”

Bedinvetmab injection is supplied as a sterile buffer 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 according to weight group to target a minimum dose of 0.5 mg/kg.1 With once-monthly injections administered by a professional veterinarian, bedinvetmab injection can also reduce pet owner stress related to forgetting 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 recruited client-owned dogs diagnosed with osteoarthritis. Half of the dogs received an injection of bedinvetmab and half of the dogs received an injection of sterile saline every 28 days for a total of 3 doses. Before treatment and on different days of 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 in controlling pain associated with osteoarthritis in dogs when at least 2 doses are administered 28 days apart.1.2

The most common adverse reactions 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 the injection site, vomiting and weight loss. Veterinarians should inform owners of possible adverse events and reactions before using the medication.

Librela received marketing authorization from the European Medicines Agency in 2020 and the product was launched in 2021. It is expected to be available in the United States in 2023.2

The references

  1. FDA approves first monoclonal antibody for dogs with osteoarthritis pain. Press 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 US FDA approval of Librela™ (bedinvetmab injection) to control osteoarthritis (OA) pain in dogs. Press release. Zoétis. May 5, 2023. Accessed May 5, 2023. https://investor.zoetis.com/news/news-details/2023/Zoetis-Announces-US-FDA-Approval-of-Librela-bedinvetmab-injection-to-Control-Osteoarthritis-OA-Pain-in-Dogs/ default.aspx

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