Dec 8 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday approved Elanco Animal Health Inc's drug for cats with a type of diabetes, making it the first oral drug to be approved for the disease in animals.
Last month, the animal healthcare company said it was preparing to launch the drug in early 2023. Elanco did not immediately respond to a Reuters request for comment after the approval.
Bexacat helps improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
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 increased appetite, with high levels of glucose in their blood and urine.
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 show 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. (Reporting by Sriparna Roy in Bengaluru; Editing by Shounak Dasgupta)