20 Dec FDA Approves Oral Treatment for Cats with Diabetes
The Food and Drug Administration announced Dec. 8 that the agency has approved the first oral animal drug to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
Bexacat is an inhibitor of sodium-glucose cotransporter 2, the first SGLT2 inhibitor approved by the FDA for any nonhuman animal species. Bexagliflozin, the active ingredient in Bexacat, prevents a cat’s kidneys from reabsorbing glucose into the blood, causing excess glucose to be passed out in the urine and resulting in lowered blood glucose. Bexacat is given to cats orally once daily via a flavored tablet.
The drug sponsor is IncreVet Inc. and Elanco Animal Health Inc. licensed development and commercialization rights for bexagliflozin from BexCaFe, an affiliate of IncreVet.
An SGLT2 inhibitor is not insulin and is not for use in cats with diabetes mellitus that requires insulin treatment. The labeling for Bexacat includes a boxed warning regarding the need for appropriate patient selection and the potential for certain severe adverse reactions.
Although there are notable safety concerns with the use of Bexacat, according to the FDA, they can be mitigated by carefully screening cats before starting the drug, continued diligent monitoring regardless of the duration of or response to treatment, and knowing how to promptly recognize and appropriately treat serious and life-threatening adverse reactions.
The data from two six-month field studies and an extended-use field study demonstrated that Bexacat was over 80% effective in improving glycemic control in cats with diabetes mellitus.
Clients whose cats receive Bexacat should receive a client information sheet (PDF) from Elanco informing them of the potential risks associated with Bexacat treatment, signs to watch for, and what to do if their cat becomes symptomatic. There will also be educational outreach to veterinarians to familiarize them with the appropriate use of the product, according to the FDA.
As with all animal drugs, veterinarians and clients should report any adverse events to the sponsor, which is required to provide those reports to the FDA. Veterinarians and clients may also report directly to the FDA.