FREE Breaking News Alerts from StreetInsider.com!
StreetInsider.com Top Tickers, 11/2/2023
LOS ANGELES, Nov. 02, 2023 (GLOBE NEWSWIRE) — The Pet Innovation Awards, an independent recognition platform highlighting the most innovative companies, services, and products in the highly competitive Pet Care industry, today announced it has awarded “Overall Cat Health Product of the Year” to Bexacat™, the first and only oral prescription tablet to improve glycemic control in cats with diabetes mellitus (DM) not previously treated with insulin, from Elanco Animal Health (NYSE: ELAN).
Bexacat is a once-daily tablet that works to lower blood sugar by increasing urine excretion of glucose through inhibition of sodium-glucose cotransporter 2 (SGLT2). The result is effective glycemic control.
“Bexacat removes some of the traditional challenges associated with treating feline diabetes and is a more efficient option for today’s on-the-go pet owner lifestyle. By providing an oral tablet and removing the barriers associated with insulin injections, Bexacat is a convenient, needle free alternative, which is why we named it our ‘Overall Cat Health Product of the Year,’” said Travis Grant, Managing Director, Independent Innovation Awards. “Traditionally, insulin injections have been the only way to manage diabetes in cats. Designed for convenience, the search for an insulin alternative for feline diabetes is over.
An estimated 600,000 cats in the U.S. are diagnosed with diabetes during their lifetime.1,2 Research shows that 125,000 cats go untreated, partially because traditional treatments require frequent dosing and additional supplies.3 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 needle-free and dosed to felines at a minimum weight of 6.6 lbs in order to ensure dosing accuracy. This therapeutic is indicated to improve glycemic control in otherwise healthy cats with DM not previously treated with insulin. It is flavored and can be taken with or without food.
The medication is the first SGLT2 inhibitor approved by the FDA in any animal species.
“We’re thrilled to be recognized by Pet Innovation for this breakthrough therapeutic that is helping address an important health need of today’s cats,” said Dr. Ellen de Brabander, Executive Vice President, Innovation and Regulatory Affairs at Elanco. “We strive to be the partner of choice for innovators, farmers and veterinarians and remain focused on delivering consistently science based, high impact innovation to reach the world’s animals.”
1 AVMA 2022 Pet Ownership and Demographic Sourcebook2 Feline Diabetes | Cornell University College of Veterinary Medicine3 Elanco Animal Health. Data on File.
The mission of the annual Pet Innovation Awards Program is to honor innovation and recognize excellence, hard work and success in a range of Pet Care industry categories, including Apparel, Grooming & Cleaning, Food & Treats, Health, Housing, Toys, Training, Retailers & Services and more. The 2023 Pet Innovation Awards attracted more than 2,000 nominations from around the world.
Indication:Bexacat is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
Important Safety Information:Before using this product, it is important to read the entire product insert, including the boxed warning. See package insert for full prescribing information.Cats treated with Bexacat may be at an increased risk of diabetic ketoacidosis or euglycemic diabetic ketoacidosis, both of which may result in death. Development of these conditions should be treated promptly, including insulin administration and discontinuation of Bexacat. 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. The use of Bexacat in cats with insulin-dependent diabetes mellitus, or the withdrawal of insulin and initiation of Bexacat, is associated with an increased risk of diabetic ketoacidosis or euglycemic diabetic ketoacidosis and death. Sudden onset of hyporexia/anorexia, lethargy, dehydration, diarrhea that is unresponsive to conventional therapy, or weight loss in cats receiving Bexacat should prompt immediate discontinuation of Bexacat and assessment for diabetic ketoacidosis, regardless of blood glucose level. Bexacat should not be initiated in cats with pancreatitis, anorexia, dehydration, or lethargy at the time of diagnosis of diabetes mellitus, as it may indicate the presence of other concurrent disease and increase the risk of diabetic ketoacidosis. Due to risk of severe adverse reactions, do not use Bexacat in cats with evidence of hepatic disease or reduced renal function. Consult a physician in case of accidental ingestion by humans.
To learn more about Bexacat, visit:
Bexacat: Insulin-Free Feline Diabetes Treatment | Elanco
Elanco Announces FDA Approval of Bexacat™ (bexagliflozin tablets) – the First-of-its-Kind Oral Feline Diabetes Treatment Option
Bexacat, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
©2023 Elanco or its affiliates. PM-US-23-1723
About The Pet Innovation Awards
Part of Independent Innovation Awards organization, a global market intelligence and recognition program within the most competitive consumer categories, The Pet Innovation Awards honors the most outstanding and innovative companies, services, and products within the rapidly expanding pet care industry. The Pet Innovation Awards provides public recognition for achievements of pet care industry companies and products including Apparel, Grooming & Cleaning, Food & Treats, Health, Retailers & Services and more. For more informationvisit: https://petinnovationawards.com.
About ElancoElanco 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.
15 mg flavored tablets For oral use in cats onlySodium-glucose cotransporter 2 (SGLT2) inhibitorCAUTIONFederal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTIONBexacat (bexagliflozin tablets) are flavored pentagonal, 10 mm, speckled white, brown, or tan biconvex with a characteristic odor. The empirical formula is C24H29ClO7 and the molecular weight is 464.94 g/mol. The chemical name is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-(2- cyclopropoxyethoxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol.The chemical structure of bexagliflozin is:
INDICATIONBexacat is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.DOSAGE AND ADMINISTRATIONAlways provide the Client Information Sheet with the prescription.Dosing InstructionsAdminister one tablet by mouth to cats weighing 6.6 lbs (3.0 kg) or greater once daily, at approximately the same time each day, with or without food, and regardless of blood glucose level.Monitoring
For more information refer to CONTRAINDICATIONS and WARNINGS.
WARNINGSUser Safety WarningsNot for use in humans. Keep out of reach of children. Consult a physician in case of accidental ingestion by humans.Animal Safety Warnings
ADVERSE REACTIONSField StudyEighty-four cats with newly diagnosed diabetes mellitus were enrolled in a 180-day multicenter field effectiveness and safety study. Safety data were evaluated in 84 cats treated with at least one dose of Bexacat. All cats received one tablet, once daily, regardless of body weight or blood glucose level. Seventy-two of the 84 enrolled cats completed the study. The most common adverse reactions included elevated blood urea nitrogen (BUN), vomiting, elevated urine specific gravity (USG), elevated serum fPL, diarrhea, anorexia, lethargy, and dehydration. The adverse reactions seen during the field study are summarized in Table 1 below.
Table 1. Adverse Reactions (n=84)
* Most cats had elevations
Nine serious adverse reactions associated with Bexacat administration occurred during the study, including three cats who died or were euthanized. Of the three cats who died or were euthanized, two cats became clinically ill within 5 doses of Bexacat administration (range 3 to 5 doses).One cat with euglycemic diabetic ketoacidosis and hepatic lipidosis was euthanized due to further deterioration of its clinical condition, despite supportive treatment. One cat demonstrating anorexia, lethargy, dehydration, azotemia, and hypokalemia was euthanized without supportive treatment. One cat, who demonstrated a lack of effectiveness, anemia and hepatic lipidosis died on Day 77 despite supportive treatment and additional diagnostics. Six of the nine cats had serious adverse reactions that did not result in death or euthanasia. Five cats were treated for their clinical conditions and transitioned to insulin. Serious adverse reactions in these cats were associated with the following conditions (number of cats): euglycemic diabetic ketoacidosis (1); lack of effectiveness, diabetic ketoacidosis, elevated liver parameters (1); diabetic ketoacidosis (1); diabetic ketoacidosis and pyelonephritis (1); and lack of effectiveness, weight loss, dehydration (1). One cat with constipation and pancreatitis received supportive treatment and remained on Bexacat (bexagliflozin tablets).
Pilot Field StudyEighty-nine cats with newly diagnosed diabetes mellitus were enrolled in a 56-day multicenter pilot field effectiveness and safety study, with continued use for up to 180 days. All cats received one tablet, once daily, regardless of body weight or blood glucose level. Safety data were evaluated for all 89 cats treated with at least one dose of bexagliflozin. The most common adverse reactions included elevated blood urea nitrogen (BUN), elevated urine specific gravity (USG), elevated serum feline pancreas-specific lipase, vomiting, diarrhea/loose stool, hyporexia/anorexia, lethargy, elevated serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), and urinary tract infections. The adverse reactions seen in the pilot study are summarized in Table 2 below.
Table 2. Adverse Reactions (n=89)
* Most cats had elevations ≤ 1.5X upper limit of normal (ULN).† Elevations were predominantly attributable to dehydration and/or glucosuria.‡ Most cats had one or more isolated elevations, followed by a return to previous values.
§ Most elevations were ≤ 2X ULN. One cat had marked ALT and AST (9X and 6X upper limit of normal, respectively) elevations on Day 28. Following discontinuation of bexagliflozin, the liver enzymes decreased within 24 hours and returned to within reference range in 10 days.** Observations included hiding, hyperactivity, vocalization, and abnormal behavior.
Twenty cats (22%) had at least one blood glucose value Extended Use Field StudyOne hundred twenty-five cats with diabetes mellitus that had previously completed a bexagliflozin field study were enrolled in a multicenter extended use field study. Cats were enrolled in the study for a range of 7 to 1064 days, with a mean of 329 days. Safety data were evaluated for all 125 cats treated with at least one dose of Bexacat (bexagliflozin tablets). All cats received one tablet, once daily, regardless of body weight or blood glucose level. Forty-nine of the 125 enrolled cats were withdrawn from the study due to adverse reactions, serious adverse reactions, death/euthanasia, lack of effectiveness, suspected diabetic remission, withdrawal of owner consent, or lost to follow up. The most common adverse reactions were similar to those noted in the previous field studies and included elevated USG (35.2%), vomiting (27.2%), elevated fPL (26.4%), anorexia (24.0%), diarrhea (22.4%), urinary tract infections (17.6%), lethargy (16.8%), and death (16.0%).Twenty serious adverse reactions associated with Bexacat administration occurred during the study, all resulting in death or euthanasia. Clinical signs of hypoglycemia were observed in two of these cats. Deaths were associated with the following conditions (number of cats), with some cats experiencing multiple comorbidities (necropsy was not granted in all cases): euglycemic diabetic ketoacidosis (8); diabetic ketoacidosis (4); hepatic lipidosis (5); pancreatic necrosis/peripancreatic fat saponification (3); urothelial carcinoma (2); hypercalcemia, recurrent calcium containing cystic calculi (1); lack of effectiveness, weight loss, anorexia (1); lethargy, weight loss, pallor (1); chronic renal disease, glomerulonephritis (1); chronic enteropathy (1); hypoglycemia, possible pancreatitis (1).CONTACT INFORMATIONTo report suspected adverse events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US Inc at 1-888-545-5973.For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.INFORMATION FOR CAT OWNERSOwners should be given the Client Information Sheet to read before Bexacat is administered. Owners should be advised to discontinue Bexacat and contact a veterinarian immediately if their cat develops anorexia, lethargy, vomiting, diarrhea, or weakness.CLINICAL PHARMACOLOGYMechanism of ActionBexagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2), the renal transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, bexagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion.PharmacokineticsIn a laboratory pilot study conducted to determine the prandial state of maximum exposure, systemic exposure for bexagliflozin was greater in the fasted state than in the fed state by 82% for the mean maximum observed plasma concentration (Cmax), and by 54% for the mean area under the plasma concentration versus time curve (AUC) from dosing (time 0) to the last quantifiable concentration (AUC0-last), respectively.
In a well-controlled margin of safety study (see Target Animal Safety), mean Cmax was approximately dose-proportional over a dosage range of 5 mg/kg (1X) to 25 mg/kg (5X). Mean AUC from time 0 to 24 hours exposure was approximately dose-proportional over a dosage range of 5 to 15 mg/kg, but more than dose-proportional at 15 to 25 mg/kg. An increase in exposure (AUC0-24 and Cmax), was observed in female cats compared to male cats on all evaluation days. Median time to reach peak plasma concentration (Tmax) was approximately 0.5 hours (range 0.5 to 2 hours) and mean half-life (T1/2) was approximately 5 hours across all dose groups. There was no accumulation of bexagliflozin following daily dosing of 5, 15, and 25 mg/kg in healthy non-diabetic cats. However, field studies showed that some diabetic cats had persistent bexagliflozin blood levels after discontinuation of the drug, which may be related to a decrease in liver function in some cats (see Animal Safety Warnings).
EFFECTIVENESSField StudyEighty-four cats diagnosed with diabetes mellitus were enrolled in a 180-day multicenter field effectiveness and safety study. Enrolled cats included purebreds and mixed breeds, ranging in age from 3 to 19 years, and weighing between 7.3 to 24.3 lbs (3.3 to 11.3 kg). Cats received one tablet, once daily, regardless of body weight or blood glucose level. Treatment success was defined as improvement in at least one blood glucose variable (blood glucose curve mean or fructosamine) and improvement in at least one clinical sign of diabetes mellitus (polyuria, polydipsia, polyphagia, or body weight [weight gain or no weight loss]).Of 77 cats included in the effectiveness-evaluable population:
Pilot Field StudyEighty-nine cats diagnosed with diabetes mellitus were enrolled in a 56-day, multicenter pilot field effectiveness and safety study with continued use for up to 180 days. Enrolled cats included purebreds and mixed breeds, ranging in age from 3 to 17 years and weighing 6.4 to 22.9 lbs (2.9 to 10.4 kg). Cats received one tablet, once daily, regardless of weight. Treatment success was defined as improvement in at least one blood glucose variable (blood glucose curve mean or fructosamine) and improvement in at least one clinical sign of diabetes mellitus (polyuria, polydipsia, polyphagia, or body weight [weight gain or no weight loss]). Of the 72 cats included in the effectiveness-evaluable population, 58 (80.6%) were considered treatment successes on Day 56.
TARGET ANIMAL SAFETYIn a well-controlled laboratory margin of safety study, Bexacat was administered orally to 28 fasted, healthy, lean, intact adult cats at doses of at least 1X (8 cats), 3X (8 cats), and 5X (12 cats) the maximum exposure dose (5 mg/kg) once daily for 26 weeks. The control group (8 cats) was sham dosed. The maximum exposure dose (5 mg/kg) was based on the assessment that the minimum weight of an eligible cat with diabetes mellitus is approximately 3 kg. Polyuria, glucosuria (with a corresponding increase in food consumption), loose stools and diarrhea, and ketonuria were reported more frequently in cats that received Bexacat than in control cats. There were drug-related clinically insignificant increases in calcium, magnesium, and cholesterol levels, and decreases in creatinine and amylase levels, and blood pressure and heart rate values. Gross necropsy demonstrated treatment-related observations of mild, diffuse zonal patterns in the liver. One cat with the observed zonal pattern had mild elevations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and a histopathological observation of minimal, multifocal necrosis in the liver. The histopathological finding did not correspond to the zonal patterns observed grossly. There were no clinically relevant, drug-related effects on hematology and coagulation parameters and organ weight values.STORAGE CONDITIONS Bexacat should be stored at room temperature 68 to 77 ˚F (20 to 25 °C).HOW SUPPLIEDFlavored tablet each containing 15 mg bexagliflozin; 30 or 90 tablets per bottle.Approved by FDA under NADA # 141-566 Manufactured for: Elanco US Inc, Greenfield, IN 46140Bexacat, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.© 2022 Elanco or its affiliatesSeptember 2022