ELAN - Elanco oral diabetes therapy for cats granted FDA approval

The U.S. Food and Drug Administration (FDA) announced Thursday the approval of Bexacat tablets developed by Elanco Animal Health Incorporated ( NYSE: ELAN ) for diabetes mellitus in cats.

Accordingly, Bexacat will be indicated in the U.S. to improve glycemic control “in otherwise healthy cats with diabetes mellitus not previously treated with insulin,” the FDA said, adding that the treatment is not for use in cats with an insulin-dependent form of DM.

According to the regulator, Bexacat, also known as bexagliflozin, is the first sodium-glucose cotransporter 2 (SGLT2) inhibitor approved for any animal species.

Bexacat was 80% effective in improving glycemic control in cats with DM in two six-month field studies and an extended-use field study, the FDA said, detailing the reasons behind its decision.

However, the approval comes with a boxed warning due to the risk of certain severe adverse reactions and the need for proper patient selection.

The approval comes ahead of the 2023 timeline the company indicated for the decision with its Q3 results in November.

Read: Elanco ( ELAN ) witnessed a ~9% YoY decline in its Q3 2022 revenue as revenue from its pet health segment contracted ~11% YoY to $471M.

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