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Bexacat™ (bexagliflozin tablets), the First and Only Tablet to Treat Feline Diabetes, Named “Overall Cat Health Product Of The Year” In 2023 Pet Innovation Awards

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Pet Innovation Awards

Pet Innovation Awards

Annual Awards Program Recognizes Top Companies, Services and Products Within the Global Pet Industry

LOS ANGELES, Nov. 02, 2023 (GLOBE NEWSWIRE) — The Pet Innovation Awards, an impartial recognition platform highlighting probably the most revolutionary firms, companies, and merchandise within the extremely aggressive Pet Care business, in the present day introduced it has awarded “Overall Cat Health Product of the Year” to Bexacat™, the primary and solely oral prescription pill to enhance glycemic management in cats with diabetes mellitus (DM) not beforehand handled with insulin, from Elanco Animal Health (NYSE:ELAN).

Bexacat is a once-daily pill that works to decrease blood sugar by growing urine excretion of glucose by inhibition of sodium-glucose cotransporter 2 (SGLT2). The result’s efficient glycemic management.

“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,’” mentioned 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,” mentioned 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 Sourcebook
2 Feline Diabetes | Cornell University College of Veterinary Medicine
3 Elanco Animal Health. Data on File.

The mission of the annual Pet Innovation Awards Program is to honor innovation and acknowledge excellence, laborious work and success in a spread of Pet Care business classes, together with Apparel, Grooming & Cleaning, Food & Treats, Health, Housing, Toys, Training, Retailers & Services and extra. The 2023 Pet Innovation Awards attracted greater than 2,000 nominations from world wide.

Indication:
Bexacat is indicated to enhance glycemic management in in any other case wholesome cats with diabetes mellitus not beforehand handled with insulin.

Important Safety Information:
Before utilizing this product, it is very important learn the complete product insert, together with the boxed warning. See package insert for full prescribing info.
Cats handled with Bexacat could also be at an elevated danger of diabetic ketoacidosis or euglycemic diabetic ketoacidosis, each of which can end in loss of life. Development of those circumstances ought to be handled promptly, together with insulin administration and discontinuation of Bexacat. Do not use Bexacat in cats with diabetes mellitus who’ve beforehand been handled with insulin, who’re 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 related to an elevated danger of diabetic ketoacidosis or euglycemic diabetic ketoacidosis and loss of life. Sudden onset of hyporexia/anorexia, lethargy, dehydration, diarrhea that’s unresponsive to traditional remedy, or weight reduction in cats receiving Bexacat ought to immediate fast discontinuation of Bexacat and evaluation for diabetic ketoacidosis, no matter blood glucose stage. Bexacat shouldn’t be initiated in cats with pancreatitis, anorexia, dehydration, or lethargy on the time of prognosis of diabetes mellitus, as it might point out the presence of different concurrent illness and improve the chance of diabetic ketoacidosis. Due to danger of extreme opposed reactions, don’t use Bexacat in cats with proof of hepatic illness or diminished renal perform. Consult a doctor in case of unintentional ingestion by people.

To study extra about Bexacat, go to:

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 brand are logos of Elanco or its associates.

©2023 Elanco or its associates. PM-US-23-1723

About The Pet Innovation Awards

Part of Independent Innovation Awards organization, a world market intelligence and recognition program inside probably the most aggressive client classes, The Pet Innovation Awards honors probably the most excellent and revolutionary firms, companies, and merchandise inside the quickly increasing pet care business. The Pet Innovation Awards offers public recognition for achievements of pet care business firms and merchandise together with Apparel, Grooming & Cleaning, Food & Treats, Health, Retailers & Services and extra. For extra info
go to: https://petinnovationawards.com.

About Elanco
Elanco Animal Health (NYSE: ELAN) is a world chief in animal well being devoted to innovating and delivering services to forestall and deal with illness in cattle and pets, creating worth for farmers, pet homeowners, veterinarians, stakeholders, and society as an entire. With almost 70 years of animal well being heritage, we’re dedicated to serving to our prospects enhance the well being of animals of their care, whereas additionally making a significant impression on our native and international communities. At Elanco, we’re pushed by our imaginative and prescient of Food and Companionship Enriching Life and our strategy to sustainability, Elanco Healthy Purpose™– all to advance the well being of animals, individuals, the planet and our enterprise. Learn extra at www.elanco.com.

15 mg flavored tablets For oral use in cats solely
Sodium-glucose cotransporter 2 (SGLT2) inhibitor
CAUTION
Federal regulation restricts this drug to make use of by or on the order of a licensed veterinarian.

WARNING: DIABETIC KETOACIDOSIS/EUGLYCEMIC DIABETIC KETOACIDOSIS

  • Cats handled with Bexacat could also be at an elevated danger of diabetic ketoacidosis or euglycemic diabetic ketoacidosis (see Adverse Reactions). As diabetic ketoacidosis and euglycemic diabetic ketoacidosis in cats handled with Bexacat might end in loss of life, growth of those circumstances ought to be handled promptly, together with insulin administration and discontinuation of Bexacat (see Monitoring).

  • Due to the chance of creating diabetic ketoacidosis or euglycemic diabetic ketoacidosis, don’t use Bexacat in cats with diabetes mellitus who’ve beforehand been handled with insulin, who’re receiving insulin, or in cats with insulin-dependent diabetes mellitus (see Contraindications).

  • Bexacat shouldn’t be initiated in cats with anorexia, dehydration or lethargy at the time of prognosis of diabetes mellitus or with out acceptable screening assessments (see Animal Safety Warnings).

DESCRIPTION
Bexacat (bexagliflozin tablets) are flavored pentagonal, 10 mm, speckled white, brown, or tan biconvex with a attribute odor. The empirical formulation is C24H29ClO7 and the molecular weight is 464.94 g/mol. The chemical title 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 construction of bexagliflozin is:

INDICATION
Bexacat is indicated to enhance glycemic management in in any other case wholesome cats with diabetes mellitus not beforehand handled with insulin.
DOSAGE AND ADMINISTRATION
Always present the Client Information Sheet with the prescription.
Dosing Instructions
Administer one pill by mouth to cats weighing 6.6 lbs (3.0 kg) or larger as soon as day by day, at roughly the identical time every day, with or with out meals, and no matter blood glucose stage.
Monitoring

  • Sudden onset of hyporexia/anorexia, lethargy, dehydration, or weight reduction in cats receiving Bexacat ought to immediate fast discontinuation of Bexacat and evaluation for diabetic ketoacidosis, no matter blood glucose stage.

  • During therapy with Bexacat, blood glucose, fructosamine, serum β-hydroxybutyrate (BHBA), serum feline pancreas-specific lipase (fPL), liver parameters, serum ldl cholesterol and triglycerides; and physique weight and scientific indicators ought to be routinely monitored.

    • Increasing or persistently elevated feline pancreas-specific lipase or liver parameters ought to immediate additional analysis for pancreatitis and/or hepatic illness and consideration for discontinuing Bexacat.

    • BHBA is the predominate ketoacid in diabetic ketoacidosis. Bexacat ought to be discontinued if a notable discount in BHBA isn’t noticed after initiation of Bexacat, or if BHBA persistently rises after an preliminary discount.

    • Cats with growing or persistently elevated ldl cholesterol and triglyceride ranges could also be at an elevated danger for creating diabetic ketoacidosis or euglycemic diabetic ketoacidosis.

    • Bexacat ought to be discontinued if poor glycemic management, as described beneath, develops.

  • Cats might current with diabetic ketoacidosis and a standard blood glucose focus (euglycemic diabetic ketoacidosis). Delay in recognition and therapy of diabetic ketoacidosis and euglycemic diabetic ketoacidosis might end in elevated morbidity and mortality.

  • Development of diabetic ketoacidosis and euglycemic diabetic ketoacidosis requires the next actions:

    • Discontinuation of Bexacat

    • Prompt initiation of insulin remedy

    • Administration of dextrose or different carbohydrate supply, no matter blood glucose focus

    • Appropriate dietary help ought to be promptly initiated to forestall or deal with hepatic lipidosis.

For extra info check with CONTRAINDICATIONS and WARNINGS.

CONTRAINDICATIONS

  • Do not use Bexacat in cats with diabetes mellitus who’ve beforehand been handled with insulin, who’re 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 related to an elevated danger of diabetic ketoacidosis or euglycemic diabetic ketoacidosis and loss of life.

  • Due to danger of extreme opposed reactions, don’t use Bexacat in cats with proof of hepatic illness or diminished renal perform.

WARNINGS
User Safety Warnings
Not to be used in people. Keep out of attain of youngsters. Consult a doctor in case of unintentional ingestion by people.
Animal Safety Warnings

  • Persistent plasma bexagliflozin concentrations and diminished clearance of Bexacat, represented because the presence of plasma half-lives in extra of 24 hours, might end in extended scientific results equivalent to glucosuria and/or euglycemia regardless of discontinuation of Bexacat in some cats with hepatic illness and/or diminished renal perform, together with cats with clinically undetectable illness on the time of Bexacat initiation. Reduced clearance of Bexacat might contribute to persistent glucosuria, leading to an osmotic diuresis and dehydration that requires acceptable hydration help. These cats might require hospitalization, which can be protracted, for sequalae equivalent to diabetic ketoacidosis, euglycemic diabetic ketoacidosis, or hepatic lipidosis.

  • Cats ought to be screened for urinary tract infections and handled, if indicated, when initiating Bexacat. Treatment with Bexacat might improve the chance for urinary tract infections (see Adverse Reactions). Cats handled with Bexacat ought to be monitored for urinary tract infections and handled promptly. Consider discontinuation of Bexacat in cats with recurrent urinary tract infections.

  • Bexacat might trigger elevated serum calcium concentrations. Bexacat ought to be discontinued in cats with persistent will increase in serum complete calcium or ionized calcium due to elevated danger of forming calcium containing uroliths (see Adverse Reactions).

  • Keep Bexacat in a safe location out of attain of dogs, cats, and different animals to forestall unintentional ingestion or overdose.

PRECAUTIONS

  • Bexacat ought to be discontinued in cats who develop diarrhea unresponsive to traditional remedy.

  • Consider momentary discontinuation of Bexacat in cats throughout instances of decreased caloric consumption, equivalent to surgical procedure or decreased urge for food, as administration of Bexacat in these cats might improve the chance of diabetic ketoacidosis or hepatic lipidosis.

  • The osmotic diuretic results of Bexacat might contribute to inappropriate urination in some cats (see Adverse Reactions).

  • Polyphagia as a compensatory response to caloric losing from glucosuria might persist in as much as 80% of cats, regardless of proof of satisfactory glycemic management, and should result in progressive weight achieve.

  • Approximately 20-30% of cats might have persistent polyuria and/or polydipsia secondary to Bexacat-induced osmotic diuresis and could also be a danger issue for dehydration-associated diabetic ketoacidosis.

  • The concurrent use of quantity depleting medicine in cats handled with Bexacat has not been evaluated.

ADVERSE REACTIONS
Field Study
Eighty-four cats with newly identified diabetes mellitus have been enrolled in a 180-day multicenter area effectiveness and security examine. Safety information have been evaluated in 84 cats handled with at the least one dose of Bexacat. All cats obtained one pill, as soon as day by day, no matter physique weight or blood glucose stage. Seventy-two of the 84 enrolled cats accomplished the examine. The most typical opposed reactions included elevated blood urea nitrogen (BUN), vomiting, elevated urine particular gravity (USG), elevated serum fPL, diarrhea, anorexia, lethargy, and dehydration. The opposed reactions seen in the course of the area examine are summarized in Table 1 beneath.

Table 1. Adverse Reactions (n=84)

Adverse Reaction

Number (%)

Elevated BUN*

46 (54.8)

Vomiting

42 (50.0)

Elevated USG†

33 (39.3)

Elevated fPL‡

33 (39.3)

Diarrhea

32 (38.1)

Anorexia

31 (37.0)

Lethargy

17 (20.2)

Dehydration

16 (19.0)

Elevated symmetrical dimethylarginine (SDMA)

13 (15.5)

Weight loss

13 (15.5)

Urinary tract an infection

12 (14.3)

Adverse Reaction

Number (%)

Elevated ALT and/or AST§

11 (13.1)

Hypercalcemia

8 (9.5)

Behavioral modifications**

6 (7.1)

Proteinuria

5 (6.0)

Elevated creatinine

4 (4.8)

Elevated creatine kinase

4 (4.8)

Inappropriate urination

4 (4.8)

Death

3 (3.6)

Diabetic ketoacidosis

3 (3.6)

Pancreatitis

3 (3.6)

Euglycemic diabetic ketoacidosis

2 (2.4)

Hepatic lipidosis

2 (2.4)

Elevated alkaline phosphatase

2 (2.4)

Elevated complete bilirubin

2 (2.4)

Constipation

2 (2.4)

Adverse Reaction

Number (%)

Elevated creatine kinase

4 (4.5)

Inappropriate urination

4 (4.5)

Peritonitis

3 (3.4)

Constipation

3 (3.4)

Elevated creatinine

2 (2.2)

Euglycemic diabetic ketoacidosis

2 (2.2)

Diabetic ketoacidosis

2 (2.2)

Hemolytic anemia

2 (2.2)

Elevated complete bilirubin

2 (2.2)

* Most cats had elevations < 1.5 instances the higher restrict of regular (ULN).
† Elevations have been predominantly attributable to dehydration and/or glucosuria.
‡ Most cats had a number of remoted elevations, adopted by a return to earlier values.
§ Of 9 cats with elevations ≥ 1.5X ULN, 2 cats developed diabetic ketoacidosis and have been transitioned to insulin. One cat developed diabetic ketoacidosis and hepatic lipidosis leading to loss of life (euthanasia). One cat developed anemia, progressive weight reduction and fPL elevations leading to loss of life.
** Observations included hiding, agitation, aggression, vocalization, and anxious habits.

Nine severe opposed reactions related to Bexacat administration occurred in the course of the examine, together with three cats who died or have been euthanized. Of the three cats who died or have been euthanized, two cats grew to become clinically in poor health inside 5 doses of Bexacat administration (vary 3 to five doses).
One cat with euglycemic diabetic ketoacidosis and hepatic lipidosis was euthanized on account of additional deterioration of its scientific situation, regardless of supportive therapy. One cat demonstrating anorexia, lethargy, dehydration, azotemia, and hypokalemia was euthanized with out supportive therapy. One cat, who demonstrated an absence of effectiveness, anemia and hepatic lipidosis died on Day 77 regardless of supportive therapy and extra diagnostics. Six of the 9 cats had severe opposed reactions that didn’t end in loss of life or euthanasia. Five cats have been handled for his or her scientific circumstances and transitioned to insulin. Serious opposed reactions in these cats have been related to the next circumstances (variety 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 reduction, dehydration (1). One cat with constipation and pancreatitis obtained supportive therapy and remained on Bexacat (bexagliflozin tablets).

Pilot Field Study
Eighty-nine cats with newly identified diabetes mellitus have been enrolled in a 56-day multicenter pilot area effectiveness and security examine, with continued use for as much as 180 days. All cats obtained one pill, as soon as day by day, no matter physique weight or blood glucose stage. Safety information have been evaluated for all 89 cats handled with at the least one dose of bexagliflozin. The most typical opposed reactions included elevated blood urea nitrogen (BUN), elevated urine particular gravity (USG), elevated serum feline pancreas-specific lipase, vomiting, diarrhea/free stool, hyporexia/anorexia, lethargy, elevated serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), and urinary tract infections. The opposed reactions seen within the pilot examine are summarized in Table 2 beneath.

Table 2. Adverse Reactions (n=89)

Adverse Reaction

Number (%)

Elevated BUN*

51 (57.3)

Elevated USG†

43 (48.3)

Elevated fPL‡

39 (43.8)

Vomiting

39 (43.8)

Diarrhea/Loose Stool

29 (32.6)

Hyporexia/Anorexia

28 (31.4)

Lethargy

16 (18.0)

Elevated ALT and/or AST§

13 (14.6)

Urinary tract an infection

13 (14.6)

Dehydration

10 (11.2)

Elevated symmetrical dimethylarginine (SDMA)

10 (11.2)

Behavioral modifications**

9 (10.1)

Ketosis/Ketonuria

8 (9.0)

Weight loss

8 (9.0)

Proteinuria

8 (9.0)

Pancreatitis

7 (7.9)

Death

6 (6.7)

Anemia

6 (6.7)

Hepatopathy

6 (6.7)

Hypercalcemia

4 (4.5)

* Most cats had elevations ≤ 1.5X higher restrict of regular (ULN).
† Elevations have been predominantly attributable to dehydration and/or glucosuria.
‡ Most cats had a number of remoted elevations, adopted by a return to earlier values.

§ Most elevations have been ≤ 2X ULN. One cat had marked ALT and AST (9X and 6X higher restrict of regular, respectively) elevations on Day 28. Following discontinuation of bexagliflozin, the liver enzymes decreased inside 24 hours and returned to inside reference vary in 10 days.
** Observations included hiding, hyperactivity, vocalization, and irregular habits.

Twenty cats (22%) had at the least one blood glucose worth < 65 mg/dL recorded throughout 8-hour blood glucose curves. No scientific indicators of hypoglycemia have been noticed and bexagliflozin dosing was not adjusted in any cat on account of documented hypoglycemia. Nine severe opposed reactions related to bexagliflozin administration occurred in the course of the examine, together with six cats who died or have been euthanized. Of the six cats who died or have been euthanized, 5 grew to become clinically in poor health inside receiving 5 doses of bexagliflozin (vary 1 to five doses). Four of the cats have been euthanized on account of additional deterioration of their scientific situation regardless of supportive therapy. One cat died regardless of supportive therapy. Deaths have been related to the next circumstances (variety of cats): necrotizing pancreatitis and pancreatic abscess (1), pancreatitis and hepatic lipidosis (1), euglycemic diabetic ketoacidosis and extreme hepatic lipidosis (1), pancreatitis and hepatic abscesses (1), diabetic ketoacidosis (1), and chronic polyuria and polydipsia and high quality of life issues (1).
Three of 9 severe opposed reactions that didn’t end in loss of life or euthanasia included the next (variety of cats): acute hepatocellular harm (1), immune-mediated hemolytic anemia (1), and euglycemic diabetic ketoacidosis with concurrent pancreatitis and hepatopathy (1).
Two cats with severe opposed reactions demonstrated persistent bexagliflozin blood plasma ranges and elimination half-lives after discontinuation of bexagliflozin. One cat with renal and liver values inside the reference vary at screening was euthanized on account of a continued decline in scientific situation regardless of therapy for euglycemic diabetic ketoacidosis and extreme hepatic lipidosis. The second cat, famous to have IRIS (International Renal Interest Society) stage II renal illness and liver values inside the reference vary at screening, recovered following therapy for marked liver enzyme elevations above the reference vary on Day 28.
Extended Use Field Study
One hundred twenty-five cats with diabetes mellitus that had beforehand accomplished a bexagliflozin area examine have been enrolled in a multicenter prolonged use area examine. Cats have been enrolled within the examine for a spread of seven to 1064 days, with a imply of 329 days. Safety information have been evaluated for all 125 cats handled with at the least one dose of Bexacat (bexagliflozin tablets). All cats obtained one pill, as soon as day by day, no matter physique weight or blood glucose stage. Forty-nine of the 125 enrolled cats have been withdrawn from the examine on account of opposed reactions, severe opposed reactions, loss of life/euthanasia, lack of effectiveness, suspected diabetic remission, withdrawal of proprietor consent, or misplaced to observe up. The most typical opposed reactions have been just like these famous within the earlier area research 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 loss of life (16.0%).
Twenty severe opposed reactions related to Bexacat administration occurred in the course of the examine, all leading to loss of life or euthanasia. Clinical indicators of hypoglycemia have been noticed in two of those cats. Deaths have been related to the next circumstances (variety of cats), with some cats experiencing a number of comorbidities (necropsy was not granted in all circumstances): euglycemic diabetic ketoacidosis (8); diabetic ketoacidosis (4); hepatic lipidosis (5); pancreatic necrosis/peripancreatic fats saponification (3); urothelial carcinoma (2); hypercalcemia, recurrent calcium containing cystic calculi (1); lack of effectiveness, weight reduction, anorexia (1); lethargy, weight reduction, pallor (1); power renal illness, glomerulonephritis (1); power enteropathy (1); hypoglycemia, doable pancreatitis (1).
CONTACT INFORMATION
To report suspected opposed occasions, for technical help, or to acquire a replica of the Safety Data Sheet (SDS), contact Elanco US Inc at 1-888-545-5973.
For further details about reporting opposed drug experiences for animal medicine, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
INFORMATION FOR CAT OWNERS
Owners ought to be given the Client Information Sheet to learn earlier than Bexacat is run. Owners ought to be suggested to discontinue Bexacat and call a veterinarian instantly if their cat develops anorexia, lethargy, vomiting, diarrhea, or weak spot.
CLINICAL PHARMACOLOGY
Mechanism of Action
Bexagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2), the renal transporter accountable for reabsorption of glucose from the glomerular filtrate again into the circulation. By inhibiting SGLT2, bexagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby growing urinary glucose excretion.
Pharmacokinetics
In a laboratory pilot examine carried out to find out the prandial state of most publicity, systemic publicity for bexagliflozin was larger within the fasted state than within the fed state by 82% for the imply most noticed plasma focus (Cmax), and by 54% for the imply space below the plasma focus versus time curve (AUC) from dosing (time 0) to the final quantifiable focus (AUC0-last), respectively.

In a well-controlled margin of security examine (see Target Animal Safety), imply Cmax was roughly dose-proportional over a dosage vary of 5 mg/kg (1X) to 25 mg/kg (5X). Mean AUC from time 0 to 24 hours publicity was roughly dose-proportional over a dosage vary of 5 to fifteen mg/kg, however greater than dose-proportional at 15 to 25 mg/kg. An improve in publicity (AUC0-24 and Cmax), was noticed in feminine cats in comparison with male cats on all analysis days. Median time to achieve peak plasma focus (Tmax) was roughly 0.5 hours (vary 0.5 to 2 hours) and imply half-life (T1/2) was roughly 5 hours throughout all dose teams. There was no accumulation of bexagliflozin following day by day dosing of 5, 15, and 25 mg/kg in wholesome non-diabetic cats. However, area research confirmed that some diabetic cats had persistent bexagliflozin blood ranges after discontinuation of the drug, which can be associated to a lower in liver perform in some cats (see Animal Safety Warnings).

EFFECTIVENESS
Field Study
Eighty-four cats identified with diabetes mellitus have been enrolled in a 180-day multicenter area effectiveness and security examine. Enrolled cats included purebreds and combined 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 obtained one pill, as soon as day by day, no matter physique weight or blood glucose stage. Treatment success was outlined as enchancment in at the least one blood glucose variable (blood glucose curve imply or fructosamine) and enchancment in at the least one scientific signal of diabetes mellitus (polyuria, polydipsia, polyphagia, or physique weight [weight gain or no weight loss]).
Of 77 cats included within the effectiveness-evaluable inhabitants:

  • The decrease sure two-sided 90% confidence interval was 74.5%. Effectiveness was demonstrated if the decrease sure of the arrogance interval was > 66%.

  • Mean blood glucose curve imply decreased from 284 mg/dL on Day 0 to 143 mg/dL on Day 56.

  • Mean fructosamine ranges decreased from 544 µmol/L previous to Day 0 to 295 µmol/L on Day 56.

  • Improvements within the scientific indicators of polyuria, polydipsia, polyphagia, and physique weight on Day 56 have been noticed in 53 (68.8%), 57 (74.0%), 44 (57.1%), and 42 (54.6%) cats, respectively.

  • 66 cats (85.7%) accomplished the 180-day examine.

Pilot Field Study
Eighty-nine cats identified with diabetes mellitus have been enrolled in a 56-day, multicenter pilot area effectiveness and security examine with continued use for as much as 180 days. Enrolled cats included purebreds and combined breeds, ranging in age from 3 to 17 years and weighing 6.4 to 22.9 lbs (2.9 to 10.4 kg). Cats obtained one pill, as soon as day by day, no matter weight. Treatment success was outlined as enchancment in at the least one blood glucose variable (blood glucose curve imply or fructosamine) and enchancment in at the least one scientific signal of diabetes mellitus (polyuria, polydipsia, polyphagia, or physique weight [weight gain or no weight loss]). Of the 72 cats included within the effectiveness-evaluable inhabitants, 58 (80.6%) have been thought-about therapy successes on Day 56.

TARGET ANIMAL SAFETY
In a well-controlled laboratory margin of security examine, Bexacat was administered orally to twenty-eight fasted, wholesome, lean, intact grownup cats at doses of at the least 1X (8 cats), 3X (8 cats), and 5X (12 cats) the utmost publicity dose (5 mg/kg) as soon as day by day for 26 weeks. The management group (8 cats) was sham dosed. The most publicity dose (5 mg/kg) was primarily based on the evaluation that the minimal weight of an eligible cat with diabetes mellitus is roughly 3 kg. Polyuria, glucosuria (with a corresponding improve in meals consumption), free stools and diarrhea, and ketonuria have been reported extra often in cats that obtained Bexacat than in management cats. There have been drug-related clinically insignificant will increase in calcium, magnesium, and levels of cholesterol, and reduces in creatinine and amylase ranges, and blood stress and coronary heart fee values. Gross necropsy demonstrated treatment-related observations of delicate, diffuse zonal patterns within the liver. One cat with the noticed zonal sample had delicate elevations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and a histopathological commentary of minimal, multifocal necrosis within the liver. The histopathological discovering didn’t correspond to the zonal patterns noticed grossly. There have been no clinically related, drug-related results on hematology and coagulation parameters and organ weight values.
STORAGE CONDITIONS Bexacat ought to be saved at room temperature 68 to 77 ˚F (20 to 25 °C).
HOW SUPPLIED
Flavored pill every containing 15 mg bexagliflozin; 30 or 90 tablets per bottle.
Approved by FDA below NADA # 141-566 Manufactured for: Elanco US Inc, Greenfield, IN 46140
Bexacat, Elanco and the diagonal bar brand are logos of Elanco or its associates.
© 2022 Elanco or its associates
September 2022

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