Zoetic Inc.'s Solensia is also the first monoclonal antibody new animal drug approved by the FDA for use in any animal species.
The agency explained in a news release on Thursday that frunevetmab – the active ingredient in Solensia – is a cat-specific monoclonal antibody designed to recognize and attach to a protein called nerve growth factor that is involved in the regulation of pain.
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When the ingredient binds to nerve growth factor, it prevents the pain signal from reaching the brain.
Solensia was made to help the quality of life for a cat suffering from osteoarthritis.
Osteoarthritis is a degenerative condition of the joints in which the normal cartilage cushion in the joints breaks down. 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.
The condition worsens over time and Solensia was made to help improve the cat's quality of life.
"Treatment options for cats with osteoarthritis are very limited. Advancements in modern veterinary medicine have been instrumental in extending the lives of many animals, including cats. But with longer lives come chronic diseases, such as osteoarthritis," Steven M. Solomon, director of the FDA’s Center for Veterinary Medicine, said in a statement. "Today’s approval marks the first treatment option to help provide relief to cats that are suffering from this condition and may significantly improve their quality of life. We also hope that today’s approval of the first monoclonal antibody by the FDA for any animal species will expand research and development of other monoclonal antibody products to treat animal diseases."
"Feline OA pain is typically undertreated because of a lack of effective solutions that are safe to use long-term, along with how difficult it can be for cat owners to administer oral medicines2," Mike McFarland, Zoetis chief medical officer, said in a company announcement. "The approval of Solensia is a significant step forward in the control of feline OA pain. Cat owners and veterinarians alike can feel confident that Solensia, with active substance frunevetmab, a monoclonal antibody (mAb) designed specifically for felines, has been studied and demonstrated to control OA pain and help cats get back to moving more freely again."
The FDA evaluated the effectiveness of Solensia in two studies sing three clinical assessments that measured different aspects of pain associated with osteoarthritis in cats.
The trials were masked, randomized, controlled field studies involving client-owned cats with clinical signs of osteoarthritis and the subjects' veterinarians assessed the cats based on orthopedic examinations before and after treatment.
The cats' owners provided baseline scores of their felines' levels of impairment during certain activities compared to before they developed osteoarthritis. The owners then assessed their cats' responses after receiving treatment.
Overall, cats in the treatment group had better assessment scores than those in the control group.
Solensia is available only by prescription from a licensed veterinarian because professional expertise is required to properly diagnose osteoarthritis in cats, administer the injection and monitor the safe use of the product.
Solensia is given through injection once a month, with dosage based on the weight of the animal.
The most common side effects in cats treated with Solensia included vomiting, diarrhea, injection site pain, scabbing on the head and neck, dermatitis and pruritus.
The FDA said the effects were "relatively mild" without requiring "cessation of treatment."
"The FDA encourages cat owners to work with their veterinary team to report any adverse events or side effects potentially related to the use of any drug, including Solensia," the agency added.