Solensia from Zoetic Inc. is also the first new animal drug with monoclonal antibodies approved by the FDA for use in any animal species.
Agency explained in the press release on Thursday this frunevetmab – the active ingredient in Solensia – is a cat-specific monoclonal antibody that is designed to recognize and bind to a protein called nerve growth factor, which is involved in regulating 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 of cats suffering from osteoarthritis.
Osteoarthritis is a degenerative condition of the joints in which the normal cartilaginous pad in the joints breaks down. The bones in the joint rub against each other, causing pain, reduced joint movement, and sometimes the formation of bone growths or other changes in and around the joint.
The condition worsens over time and Solensia was made to help improve quality of cat life.
“The treatment options for cats with osteoarthritis are very limited. Advances in modern veterinary medicine have contributed to prolonging the lives of many animals, including cats. But with longer life expectancy come chronic diseases such as osteoarthritis,” said Steven M. Solomon, director of the Center for Veterinary Medicine. The FDA said in a statement. “Today’s approval is the first treatment option that helps cats suffering from this condition and can 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 the research and development of other monoclonal antibody products for the treatment of animal diseases. ”
“OA cat pain is usually under-treated due to a lack of effective solutions that would be safe for long-term use, along with how difficult it is for cat owners to give oral medications2,” said Mike McFarland, Zoetis ’chief physician. company notice. “The approval of Solensia is an important step forward in the control of pain in cats with OA. Cat owners and veterinarians can be confident that Solensia has been studied and proven to control pain in the active substance frunevetmab, a monoclonal antibody (mAb) designed specifically for cats. OA and help cats move more freely again. “
The FDA evaluated the effectiveness of Solensia in two studies with three clinical evaluations that measured different aspects of osteoarthritis-related pain in cats.
The experiments were covert, randomized, controlled field studies involving cats owned by a client with clinical signs of osteoarthritis, and the subjects ’veterinarians evaluated the cats based on orthopedic examinations before and after treatment.
Cat owners provided basic estimates of the degree to which their cats were affected during certain activities compared to those before they developed osteoarthritis. Owners then evaluated the responses of their cats after treatment.
Overall, the cats in the treatment group had better scores than those in the control group.
Solensia is only available with a prescription from an authorized veterinarian, as expertise is required to correctly diagnose osteoarthritis in cats, give injections and monitor the safe use of the product.
Solensia is given by injection once a month, the dose being based on the weight of the animal.
The most common side effects in Solensia-treated cats were vomiting, diarrhea, injection site pain, scabies on the head and neck, dermatitis and pruritus.
The FDA said the effects were “relatively mild” without the need to “discontinue treatment.”
“The FDA encourages cat owners to work with their veterinary team to report any adverse events or side effects that may be related to the use of any medication, including Solensia,” the agency added.