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

Rhea-AI Summary

Elanco Animal Health (NYSE:ELAN) announces FDA approval for Bexacat™ (bexagliflozin tablets), the first oral medication improving glycemic control in diabetic cats. Approximately 600,000 cats in the U.S. are diagnosed with diabetes, with 125,000 untreated due to insulin's complexities. Bexacat offers a non-insulin, once-daily treatment, enhancing convenience for pet owners. In pivotal studies, 83% of treated cats showed improvement by day 56. Bexacat is expected to be available by Q1 2023, enriching Elanco's feline health portfolio alongside other innovative products.

Positive

• FDA approval of Bexacat enhances Elanco's feline product line.
• Bexacat addresses a significant unmet need for diabetic cats.
• 83% treatment success rate within 56 days in pivotal studies.

Negative

• Bexacat carries safety warnings including risks of diabetic ketoacidosis.
• Not suitable for cats previously treated with insulin or those with renal issues.

GREENFIELD, Ind.--(BUSINESS WIRE)-- 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.

“It’s really about the human-animal bond,” said Dr. Michael Breer, Senior Director, US Pet Health Consulting Veterinarians. “When developing treatment options for pet owners, we need to consider the paradigm shift that has taken place over the past few years. More than ever, our pets are part of the family. People are apprehensive about using needles to inject their pets with medication. Bexacat integrates seamlessly into the busy lifestyle of pet owners and provides a needle-free approach to managing diabetes in cats.”

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 U.S. veterinarians in the first quarter of 2023.

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

Elanco Animal Health (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we’re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability, Elanco Healthy Purpose™– all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.

i AVMA 2022 Pet Ownership and Demographic Sourcebook
ii Feline Diabetes | Cornell University College of Veterinary Medicine
iii-iv Elanco Animal Health. Data on file.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221209005431/en/

Elanco Investor Contact: Katy Grissom (317) 273-9284 kathryn.grissom@elancoah.com

Elanco Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com

Source: Elanco Animal Health Incorporated

FAQ

What is Bexacat approved for?

Bexacat is FDA-approved to improve glycemic control in cats with diabetes mellitus.

How does Bexacat differ from traditional diabetes treatments for cats?

Bexacat is a needle-free, once-daily oral medication, unlike traditional insulin injections.

When will Bexacat be available to veterinarians?

Bexacat is expected to be available to U.S. veterinarians in Q1 2023.

What is the success rate of Bexacat in clinical studies?

In pivotal studies, 83% of treated cats showed significant improvement by day 56.

What are the safety concerns associated with Bexacat?

Safety information includes risks of diabetic ketoacidosis and is not suitable for insulin-treated cats.