By Sriparna Roy
(Reuters) -The U.S. Food and Drug Administration (FDA) on Thursday approved Elanco Animal Health (NYSE:ELAN) Inc's drug for cats with a type of diabetes, making it the first oral drug to be approved for the disease in animals.
Bexacat helps improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
The animal healthcare company expects the drug will be available to U.S. veterinarians in the first quarter of 2023, Michael Breer, Elanco's senior director for U.S. pet health consulting veterinarians, said in an email.
An estimated 600,000 cats in the United States are diagnosed with diabetes and research shows nearly 125,000 cats go untreated due to the complexity of today's options, Breer said.
Cats with diabetes mellitus often require lifelong therapy and are traditionally treated with a combination of insulin and proper diet. Without proper treatment, cats with the disease show symptoms of increased thirst and urine output, weight loss and higher appetite.
Bexacat comes with a boxed warning regarding the critical need for appropriate patient selection and the potential for certain adverse reactions such as ketoacidosis, a potentially fatal problem that causes the body to start breaking down fat at a very fast rate.
All cats that receive Bexacat should have blood tests at regular intervals after starting the treatment to help mitigate potential safety concerns of the drug, the health regulator said.
Data from two field studies showed that the drug was over 80% effective in improving glycemic control in cats suffering from the disease.
The drug should not be used in cats that have previously been treated with insulin, receiving insulin, or have insulin-dependent diabetes mellitus, as serious adverse reactions can occur, according to the FDA.