TheracosBio has announced a collaboration with Publix Super Markets to make BRENZAVVY (bexagliflozin), an FDA-approved SGLT2 inhibitor for type 2 diabetes treatment, available at the pharmacy chain's more than 1,400 locations throughout the Southeast United States. The partnership aims to address medication affordability challenges faced by patients managing type 2 diabetes.
Significant Cost Reduction for Diabetes Management
BRENZAVVY offers a substantial cost advantage for cash-paying customers, with a one-month supply priced at 90% less than other comparable SGLT2 inhibitors. "TheracosBio is committed to increasing access to effective, low-cost medications," said Brian Connelly, President and CEO of TheracosBio. "We are excited to work with Publix to provide their customers a cost-effective option to manage type 2 diabetes by offering BRENZAVVY at an affordable price."
The collaboration addresses a critical need for individuals operating on fixed budgets, who may find it difficult to consistently afford diabetes medication. Publix, identified as the largest employee-owned company in the country, provides an extensive distribution network for the medication across the Southeast region.
Clinical Efficacy and Dosing Profile
BRENZAVVY is formulated as 20 mg oral tablets designed for once-daily administration in the morning, with or without food. The medication can be initiated in adults with type 2 diabetes who have an estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL/min/1.73 m². Patients with eGFR between 30 and 59 mL/min/1.73 m² are classified as having stage 3 chronic kidney disease.
Phase 3 clinical studies demonstrated that BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar after 24 weeks of treatment. The medication showed efficacy across multiple treatment scenarios, including use as monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment regimens consisting of various agents such as metformin, sulfonylureas, insulin, DPP4 inhibitors, or combinations of these medications.
Additional Clinical Observations
While BRENZAVVY is not approved for weight loss or blood pressure reduction, modest decreases in both weight and blood pressure have been observed during the clinical program. These secondary effects may provide additional benefits for patients with type 2 diabetes, who often present with comorbid conditions including obesity and hypertension.
Safety Profile and Monitoring Requirements
BRENZAVVY carries important safety considerations typical of the SGLT2 inhibitor class. The medication can cause serious side effects including diabetic ketoacidosis, which may be fatal. Signs and symptoms of ketoacidosis include nausea, vomiting, stomach pains, tiredness, trouble breathing, and ketones in urine or blood. Notably, ketoacidosis can occur even when blood sugar levels are below 250 mg/dL.
The medication may increase the risk of lower limb amputations, with procedures mainly involving removal of the toe or part of the foot, though amputations involving the leg have also been reported. Additional risks include dehydration, urinary tract infections, genital yeast infections, and hypoglycemia.
The most common side effects observed with BRENZAVVY include vaginal yeast infections, urinary tract infections, and changes in urination patterns, including urgent and frequent urination, particularly at night.
Company Background and Mission
TheracosBio, founded in 2000, focuses on developing affordably priced novel therapeutics for diseases with significant societal impact. The company's mission centers on expanding access to new medications for patients with common diseases, aligning with the current partnership strategy to improve diabetes care accessibility.
