Elanco Announces FDA Approval of Bexacat (bexagliflozin tablets) – the First-of-its-Kind Oral Feline Diabetes Treatment Option

Today Elanco Animal Health (NYSE:ELAN) announced the U.S. Food and Drug Administration (FDA) approved Bexacat (bexagliflozin tablets), the first orally administered prescription medication to improve glycemic control in cats with diabetes mellitus, expanding Elanco’s innovative feline portfolio while addressing an unmet need for this chronic condition in adult cats.

An estimated 600,000 cats in the U.S. are diagnosed with diabetes during their lifetime, with the prevalence of this devastating disease increasing over the past decade.^i,ii Research shows 125,000 cats go untreated, partially because traditional insulin treatments require frequent dosages and additional supplies for injectable administration.ⁱⁱⁱ Left untreated, feline diabetes can result in weight loss, loss of appetite, vomiting, dehydration, severe depression, problems with motor function, coma, and even death.

Bexacat is the first sodium-glucose cotransporter 2 (SGLT2) inhibitor approved by the FDA in any animal species. Bexacat introduces a new mechanism of action for veterinarians and pet owners that offers a non-insulin, needle-free, once-daily oral medication specifically designed for cats with diabetes mellitus. This first-in-class therapeutic is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Elanco licensed development and commercialization rights for bexagliflozin from BexCaFe, an affiliate of IncreVet.

According to Dr. Catharine Scott-Moncrieff, Professor and Head of the Department of Clinical Sciences at Purdue University's College of Veterinary Medicine, “I believe that Bexacat will be a game changer for the management of cats newly diagnosed with diabetes mellitus."

In the pivotal field study, the use of Bexacat in newly diagnosed, otherwise healthy cats showed that 83% of cats were considered a treatment success by day 56, based on a significant improvement in glycemic control and at least one clinical sign associated with diabetes mellitus. In both pilot and pivotal studies, the average blood glucose levels decreased significantly within 8 hours of administration.^iv Bexacat limits the uncertainty of errors associated with dosing and is a more efficient option for today’s on-the-go pet owner lifestyle. By providing an oral tablet, Elanco seeks to improve convenience and increase compliance rates by removing the barriers associated with insulin injections.