FDA Approves Brenzavvy: A Game-Changing Type 2 Diabetes Drug

In January 2023, the FDA approved Brenzavvy (bexagliflozin), a new sodium-glucose cotransporter 2 (SGLT2) inhibitor developed by TheracosBio, for the treatment of adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control.

Brenzavvy Revolutionizes Diabetes Treatment

The FDA's Approval and Commercial Availability

The pharmaceutical industry has witnessed a remarkable breakthrough in the treatment of type 2 diabetes (T2D) with the recent approval of Brenzavvy (bexagliflozin) by the FDA. This much-awaited medication is now commercially available in the US, promising a more affordable option for patients without the need for insurance.

Brenzavvy: A Cost-Effective Diabetes Medication

Lowering the Financial Barrier

Pharmaceutical company TheracosBio has made a significant stride in making diabetes treatment more accessible to patients by offering Brenzavvy through Cost Plus Drugs. This public-benefit corporation has been established to negotiate directly with manufacturers, providing medications at a considerably reduced cost.

The Affordable Price Tag

Cost Plus Drugs is offering a 30-day supply of Brenzavvy for just $47.85, with added shipping and handling charges. This competitive price point marks a turning point in diabetes treatment, considering that similar medications have been known to cost hundreds of dollars per month.

Visionary Founders

The brainchild of Mark Cuban and physician Alexander Oshmyansky, Cost Plus Drugs has been envisioned with a mission to improve the lives of those living with diabetes. The company's commitment extends beyond Brenzavvy, with a diverse range of over 1,000 prescriptions available to consumers.

Mechanism of Action: How Brenzavvy Works

Brenzavvy (bexagliflozin) works by inhibiting sodium-gluc By blocking SGLT2, bexagliflozin reduces the reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretionose co-transporter 2 (SGLT2), a protein responsible for reabsorbing the majority of glucose from the renal glomerular filtrate in the proximal renal tubules.

This mechanism of action leads to several physiological effects:

• Increased urinary glucose excretion: By inhibiting glucose reabsorption in the kidneys, more glucose is excreted through urine, effectively lowering blood glucose levels.
• Reduced blood glucose levels: The increased urinary glucose excretion results in a decrease in both fasting and postprandial glucose concentrations.
• Mild osmotic diuresis: The increased urinary glucose excretion can lead to a mild increase in urine volume.
• Potential for weight loss: The loss of glucose through urine can contribute to a modest reduction in body weight.
• Blood pressure reduction: SGLT2 inhibition may lead to a mild decrease in blood pressure, possibly due to the osmotic diuretic effect and other factors.

It's important to note that the efficacy of Brenzavvy is dependent on renal function and blood glucose levels. The drug's glucose-lowering effect decreases with declining renal function. Additionally, Brenzavvy's mechanism of action is independent of insulin secretion or action, making it effective in patients with varying degrees of beta-cell function or insulin resistance.

The unique mechanism of SGLT2 inhibition also explains some of the potential side effects associated with Brenzavvy, such as increased risk of genital mycotic infections due to increased urinary glucose.

Benefits and Limitations of Brenzavvy

Reducing Health Complications

Brenzavvy's ability to bring down A1C levels below 7% is vital, as it reduces the risk of severe diabetes-related complications such as heart disease, kidney disease, and blindness. Patients who incorporate this drug into their treatment plan experience a considerable risk reduction.

A Weight-Loss Bonus

Participants in the clinical trials were pleasantly surprised by Brenzavvy's additional benefit—a reduction of approximately 3kg in body weight after 48 weeks. This weight loss was sustained throughout the 168-week follow-up period, offering a potential advantage to overweight individuals.

A Notable Exclusion

It's essential to note that Brenzavvy is exclusively approved for the treatment of type 2 diabetes and is not intended for individuals with type 1 diabetes. The drug's primary function is to address the specific needs of those with T2D.

Comparing Brenzavvy with Other SGLT-2 Inhibitors

Expanding Treatment Options

With the FDA's approval, Brenzavvy joins the ranks of other SGLT-2 inhibitors such as Invokana, Farxiga, Jardiance, and Steglatro. The availability of multiple treatment options aims to enhance patient choice and tailor treatment to individual needs.

Bridging the Gap in Uptake

Currently, only 12% of adults diagnosed with type 2 diabetes in the US are using SGLT-2 inhibitors. The high cost and insurance barriers associated with these medications have deterred roughly 50% of patients from continuing treatment for a year.

Conclusion: A Brighter Future for Diabetes Treatment

In conclusion, the FDA's approval of Brenzavvy signifies a promising leap in diabetes treatment, offering hope and relief to millions of patients. Its affordability, proven efficacy, and additional health benefits make it a game-changer in the fight against type 2 diabetes.