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Friday, May 5, 2023
FDA Approves First Monoclonal Antibody for Dogs with Osteoarthritis Pain
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.
From the FDA:
- On Tuesday, the U.S. Department of Justice announced the United States Marshals, acting with investigators from the FDA, seized nearly 250,000 bottles of liquid product containing kratom, 1.0 tank of liquid product containing kratom, more than 1,200 cartons of capsules containing kratom, and over 1000 kilograms of bulk powder kratom. The seized articles containing kratom were manufactured by Botanic Tonics, LLC of Broken Arrow, Oklahoma and are marketed under the brand name “Feel Free Plant Based Herbal Supplement.” The seized products are estimated to be worth more than $3 Million. The bulk kratom and articles containing kratom were seized after the U.S. Attorney’s Office in the Northern District of Oklahoma filed a civil forfeiture complaint on behalf of the FDA. The complaint alleges that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury. The complaint further states that dietary supplements containing kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.