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TheracosBio, a renowned biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for its innovative medication, Brenzavvy™ (bexagliflozin). The drug, an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, is designed to assist in the management of type 2 diabetes in adults.
1. Brenzavvy™ (bexagliflozin): An Overview
Brenzavvy™ (bexagliflozin) is a once-daily oral medication that functions as an SGLT2 inhibitor. It has shown substantive results in reducing blood glucose levels and enhancing glycemic control, providing a beneficial addition to dietary and exercise measures for those battling type 2 diabetes. However, it's important to note that Brenzavvy™ (bexagliflozin) is not recommended for individuals with type 1 diabetes or those undergoing treatment for diabetic ketoacidosis.
2. Individual Suitability for Brenzavvy™ (bexagliflozin)
Brenzavvy™ (bexagliflozin) is contraindicated for individuals who have shown hypersensitivity to bexagliflozin or any other component in the tablet. Furthermore, it is unsuitable for patients suffering from end-stage renal disease or those on dialysis.
3. Clinical Trials and FDA Approval
The FDA approved Brenzavvy™ (bexagliflozin) based on a comprehensive clinical program that involved over 5,000 adults with type 2 diabetes mellitus. The Phase 3 trials demonstrated that Brenzavvy™ (bexagliflozin) significantly reduced hemoglobin A1c and fasting blood sugar levels over a 24-week period. This efficacy was observed regardless of whether the drug was used as monotherapy, combined with metformin, or added to a variety of standard-of-care treatments.
4. Side Benefits of Brenzavvy™ (bexagliflozin)
While Brenzavvy™ (bexagliflozin) is not approved specifically for weight or blood pressure reduction, clinical trials have noted modest decreases in both weight and systolic blood pressure in patients using the medication.
5. Expert Opinions on SGLT2 Inhibitors
Dr. Mason Freeman, M.D., Director of the Translational Research Center at Massachusetts General Hospital, expressed his support for the SGLT2 inhibitor class of drugs, highlighting their immense benefits in treating adults with type 2 diabetes. He specifically commended the efficacy of Brenzavvy™ (bexagliflozin) in reducing blood glucose levels.
6. Brenzavvy™ (bexagliflozin) and Chronic Kidney Disease
Brenzavvy™ (bexagliflozin) can be prescribed to adults with type 2 diabetes possessing an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2. For patients in stage 3 chronic kidney disease (eGFR less than 60 and greater than 30 mL/min/1.73 m2), metformin is typically avoided due to the risk of lactic acidosis.
7. TheracosBio's Milestone
Albert R. Collinson, Ph.D., President and CEO of TheracosBio, heralded the FDA approval as a significant milestone for the company, emphasizing the importance of Brenzavvy™ (bexagliflozin) as a new treatment option for patients with type 2 diabetes.
8. Prevalence of Type 2 Diabetes
According to the U.S. Centers for Disease Control and Prevention, over 33 million Americans suffer from type 2 diabetes. This condition results in the body's inability to use insulin correctly, leading to high blood sugar levels. While some individuals can control their blood sugar levels through exercise and a healthy diet, others may require additional help, such as Brenzavvy™ (bexagliflozin), to achieve optimal glycemic control.
9. The Role of SGLT2 Inhibitors
SGLT2 inhibitors are a class of prescription medications designed to lower blood sugar levels. They work by facilitating the kidneys to eliminate sugar from the body via urine.
10. Dosage and Availability of Brenzavvy™ (bexagliflozin)
Brenzavvy™ (bexagliflozin) is available in 20 mg oral tablets, recommended to be taken once daily, either with or without food.
TheracosBio continues to demonstrate its commitment to developing novel therapeutics for diseases with significant societal impacts. The company's mission is to enhance access to new medications for patients with common diseases, and the approval of Brenzavvy™ (bexagliflozin) marks a significant step towards achieving this goal.
Indications:
Diabetic Ketoacidosis
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
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