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  5. Drug Trials Snapshots: BRENZAVVY
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Drug Trials Snapshots: BRENZAVVY

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the BRENZAVVY Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

BRENZAVVY (bexagliflozin)
(bren-ZA-vee)
TheracosBio
Approval date: January 20, 2023


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

BRENZAVVY is a medicine that improves blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise.

How is this drug used?

BRENZAVVY is a tablet that is taken by mouth once daily in the morning.

Who participated in the clinical trials?

The FDA approved BRENZAVVY based on evidence from nine clinical trials that enrolled 4,462 adults (2,578 of these patients received BRENZAVVY). The nine trials were conducted at 428 sites in 16 countries including the United States, Mexico, Colombia, Japan, Czech Republic, Poland, Spain, Hungary, France, Canada, Netherlands, Denmark, South Korea, Taiwan, Russia, and Germany. All nine trials were used to assess safety and six of these trials (enrolling 3,346 patients of the 4,462 patients) were used to assess the efficacy of BRENZAVVY.

How were the trials designed?

The efficacy of BRENZAVVY was evaluated in six clinical trials, while the safety of BRENZAVVY was evaluated in nine clinical trials of adults with type 2 diabetes whose blood sugar was not well controlled. All patients were required to follow diet and exercise recommendations, but the trials differed with respect to which other drugs patients were allowed to use for diabetes treatment.

In four trials, patients were randomly assigned to receive either BRENZAVVY or placebo by mouth once daily. In two trials, they received either BRENZAVVY or a different diabetes medicine. Neither the patients nor the healthcare providers knew which treatment patients received until after the trial was completed.

The benefit of BRENZAVVY was evaluated by the change in hemoglobin A1c (HbA1c) between the BRENZAVVY and the comparator (either placebo or another diabetes medicine) at the end of the treatment period.


WHO WAS IN THE CLINICAL TRIALS?

Figure 1 summarizes how many females and males were enrolled in the combined six clinical trials used to evaluate the efficacy of BRENZAVVY.

Figure 1. Baseline Demographics of Six Global Efficacy Trials by Sex

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 2,166 (65%) male patients and 1,180 (35%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes how many participants by race were enrolled in the combined six clinical trials used to evaluate the efficacy of BRENZAVVY.

Figure 2. Baseline Demographics by Race

Pie chart summarizing how many White, Black or African American, Asian, and other patients were in the clinical trial. In total, 2,449 (73%) White patients, 192 (6%) Black or African American patients, 535 (16%) Asian patients, and 170 (5%) other patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 3 summarizes how many participants by age were enrolled in the combined six clinical trials used to evaluate the efficacy of BRENZAVVY.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many patients by age were in the clinical trial. In total, 1,889 (56%) patients younger than 65 years of age and 1,457 (44%) patients 65 years of age and older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes how many participants by ethnicity were enrolled in the combined six clinical trials used to evaluate the efficacy of BRENZAVVY.

Figure 4. Baseline Demographics by Ethnicity

Pie chart summarizing how many Hispanic, not Hispanic, and not reported patients were in the clinical trial. In total, 560 (17%) Hispanic or Latino patients, 2,785 (83%) not Hispanic or Latino patients, and 1 (<1%) not reported patients participated in the clinical trial.

Source: Adapted from FDA Review

What are the benefits of this drug?

In adults with type 2 diabetes treatment with BRENZAVVY can lower HbA1c. HbA1c is a measure of blood sugar control over the last 8 to 12 weeks.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age?

  • Sex: BRENZAVVY worked similarly in males and females.
  • Race: BRENZAVVY worked similarly in Asians, Black or African Americans, and Whites. The number of patients of other races was limited; therefore, differences in response among other races could not be determined.
  • Age: BRENZAVVY worked similarly in adults younger and older than 65 years of age.

What are the possible side effects?

BRENZAVVY may cause ketoacidosis, a serious, potentially life-threatening complication that occurs when the body produces high levels of acids in the blood. BRENZAVVY may also cause serious side effects such as an increased incidence for surgery to remove parts of the legs or feet, decreases in blood pressure due to excessive loss of water and sodium from the body, serious infections in the genital region (Fournier’s gangrene), very low blood sugar levels when used in combination with insulin or medications that increase insulin in the body, and serious urinary tract infections. Serious urinary tract infections can spread to the kidneys (pyelonephritis) or cause a serious, potentially life-threatening blood infection (urosepsis).

The most common side effects with BRENZAVVY are genital yeast infections, urinary tract infections, and increased urination.

Were there any differences in side effects among sex, race and age?

  • Sex: More genital yeast infections were seen in females taking BRENZAVVY compared to males. In clinical trials, all patients treated with BRENZAVVY had more genital yeast infections compared to patients given placebo.
  • Race: The occurrence of side effects was similar between American Indian or Alaska Native, Asian, Black or African American, and White patients.
  • Age: The occurrence of side effects was similar between adults younger and older than 65 years of age.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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