Elanco Announces FDA Approval of Bexacat™ (bexagliflozin tablets) – the First-of-its-Kind Oral Feline Diabetes Treatment Option
An estimated 600,000 cats in the
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.
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.
“It’s really about the human-animal bond,” said Dr.
The approval of Bexacat expands Elanco’s existing feline portfolio of innovative solutions that address the health needs of today’s cats, along with products such as Zorbium™ (buprenorphine transdermal solution), Credelio® Cat (lotilaner), and Elura® (capromorelin oral suspension). This announcement reinforces Elanco’s commitment to pioneering solutions in the underserved chronic disease state and feline market through a growing portfolio of treatment options.
Bexacat is anticipated to be available to
Important Safety Information: Before using Bexacat, read the entire product insert, including the boxed warning. Call 1-888-545-5973 for full prescribing information.
Caution: Federal law restricts this drug to be used by or on the order of a licensed veterinarian. Not for use in humans. Keep out of reach of children. Consult a physician in case of accidental ingestion by humans. Cats treated with Bexacat may be at an increased risk of diabetic ketoacidosis or euglycemic diabetic ketoacidosis, both of which may result in death. Do not use Bexacat in cats with diabetes mellitus who have previously been treated with insulin, who are receiving insulin, or in cats with insulin-dependent diabetes mellitus. Due to risk of severe adverse reactions, do not use Bexacat in cats with evidence of hepatic disease or reduced renal function. See Animal Safety Warnings and Precautions for other important criteria and screening tests prior to initiating treatment with Bexacat. Discontinue Bexacat and contact a veterinarian immediately if the cat develops anorexia, lethargy, vomiting, diarrhea, or weakness.
Important Safety Information: Before using Zorbium, read the entire package insert including the boxed human warning. Call 1-888-545-5973 for full prescribing information or visit http://www.elancolabels.com/us/zorbium.
ABOUT ELANCO
i AVMA 2022 Pet Ownership and Demographic Sourcebook
ii Feline Diabetes |
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Elanco Investor Contact:
Elanco Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com
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