FDA Committee Recommends New Diabetes Drug

Dapagliflozin benefits outweigh possible risks according to committee

(RxWiki News) A committee within the US Food and Drug Administration (FDA) recently voted that a unique type of drug could benefit type 2 diabetes patients.

The drug, dapagliflozin (brand name Forxiga) was being reviewed by the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).

FDA EMDAC voted that the benefits of dapagliflozin outweigh the drug's possible heart health risks.

Although the FDA is not required to approve dapagliflozin based on the committee's recommendation, the agency takes its advice into consideration.

"Talk to your doctor about treatment options for type 2 diabetes."

Diabetes is a condition in which the body fails to regulate its own blood sugar, which can result in heart disease, kidney failure, and blindness.

Dapagliflozin inhibits certain types of proteins that allow for glucose, or sugar, to reabsorb into the kidneys. The sugar is then transported out of the body through the urine.

When dapagliflozen was first submitted for FDA review, potential safety concerns — including bladder cancer, liver injury, and heart health problems — led the committee to delay approval until there was more research on the drug.

Recently, the makers of the drug submitted clinical study reports and other safety information about the drug.

63 studies were included in the new application, each with a duration of 12 weeks or more.

The studies found that there were only 10 cases of bladder cancer among 6,045 patients treated with dapagliflozin. One in 3,512 patients treated with a comparison drug developed bladder cancer.

An analysis of clinical trials of the drug looked for heart health problems, including heart attack, stroke and death from a heart-related health issue.

Researchers found that dapagliflozin did lead to an increase in heart health-related events, but the increase was within the FDA limits for acceptable risks.

EMDAC noted that drug-induced liver injury may be an adverse event related to the dapagliflozin, but not at rates that significantly outpace similar diabetes drugs.

The committee also noted that dapagliflozin is linked to genital and urinary tract infections as well as dehydration, which could cause long-term problems. 

Ultimately EMDAC voted 13-1 that the benefits of the drug outweigh the possible risks. Additionally, they voted 10-4 that the drug has an acceptable heart health risk profile.

The announcement was made on December 12.

Review Date: 
December 13, 2013