First oral diabetes treatment for cats receives FDA approval

Officials with the FDA have approved the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Bexagliflozin tablets (Bexacat; Increvet Inc) is also the first sodium-glucose cotransporter 2 (SGLT2) inhibitor new animal drug approved by the FDA in any animal species.

Cats with diabetes mellitus cannot properly produce or respond to the hormone insulin, which helps cells use glucose as a source of energy for normal function. Without treatment, cats with diabetes mellitus will have high levels of glucose in their blood and urine. The first symptoms of diabetes mellitus are usually increased thirst and urine output, weight loss, and increased appetite. Diabetes mellitus in cats often requires lifelong therapy.

Bexagliflozin oral tablets are administered to cats weighing 6.6 lbs or greater once daily, at approximately the same time each day, with or without food and regardless of blood glucose level. The drug product is available in 15mg flavored tablets in 30 and 90-count bottles.

Cats with diabetes mellitus have been traditionally treated with a combination of insulin therapy and diet. Insulin therapy requires owners to administer insulin injections, usually twice a day, roughly 12 hours apart at the same time each day. Bexagliflozin, the active ingredient in the new therapy, prevents the 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.

The data from two 6-month field studies and an extended use field study demonstrated that bexagliflozin tablets was more than 80% effective in improving glycemic control in cats with diabetes mellitus. However, potential patients must be selected carefully and screened to evaluate for kidney, liver, and pancreatic disease as well as ketoacidosis. This therapy should not be used in cats who have previously been treated with insulin, are receiving insulin treatment, or who have insulin-dependent diabetes mellitus, as serious adverse reactions can occur. It should also not be initiated in cats who are not eating well, dehydrated, or lethargic when diagnosed with diabetes mellitus.

Cats treated with bexagliflozin tablets may be at an increased risk of serious adverse reactions, including diabetic ketoacidosis or euglycemic diabetic ketoacidosis, which can be fatal. Cats with diabetic ketoacidosis or euglycemic ketoacidosis should be treated as emergencies, including discontinuation of bexagliflozin tablets and initiation of insulin therapy. All cats who receive bexagliflozin tablets should be examined and have blood tests at regular intervals following initiation of treatment. Cats should be carefully monitored for lack of appetite, lethargy, dehydration, and weight loss. Cat owners who note any of these signs should stop Bexacat treatment and immediately take the cat to a veterinarian, who should assess the cat for diabetic ketoacidosis or euglycemic diabetic ketoacidosis.

Although there are notable safety concerns with the use of bexagliflozin tablets, the FDA advised that 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.

Clients whose cats receive bexagliflozin tablets should receive an information sheet informing them of the potential risks associated with the treatment, signs to watch for, and what to do if their cat becomes symptomatic. According to the FDA, there will also be educational outreach to veterinarians to familiarize them with the appropriate use of the product prior to prescribing its use.

Reference

FDA Approves First Oral Treatment for Cats with Diabetes Mellitus. FDA. December 8, 2022. Accessed December 8, 2022. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-oral-treatment-cats-diabetes-mellitus