<--GAT-->

New SGLT2 Inhibitor Approved to Treat Type 2 Diabetes

by U.S. Medicine

February 5, 2014

WASHINGTON A new sodium-glucose co-transporter 2 (SGLT2) inhibitor has been approved to treat type 2 diabetes.

The Food and Drug Administration approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults. Farxiga is marketed by Bristol-Myers Squibb Company, Princeton, NJ, and AstraZeneca Pharmaceuticals LP, Wilmington, DE.

Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes,” said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

SGLT2 inhibitors block the reabsorption of glucose by the kidney, increase glucose excretion and lower blood glucose levels.

Farxiga’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The drug was shown to improve patients HbA1c measurements.

The studies involved Farxiga both as a monotherapy and in combination with other type 2 diabetes medications, including metformin, pioglitazone, glimepiride, sitagliptin and insulin.

The FDA noted that Farxiga should not be used to treat people with type 1 diabetes, diabetic ketoacidosis or moderate or severe renal impairment, end stage renal disease or who are on dialysis.

Because an increased number of bladder cancers were diagnosed among Farxiga users in clinical trials, the FDA also does not recommend Farxiga is not recommended for patients with active bladder cancer and suggests that patients with a history of bladder cancer talk to their physician before initiation of the therapy.

Farxiga can cause dehydration, leading to hypotension that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function and patients on diuretics to treat other conditions appeared to be more susceptible to this risk, the FDA said.

Six post-marketing studies are being required for Farxiga.

Genital mycotic (fungal) infections and urinary tract infections are among the drug’s side effects.


Related Articles

VA/National Cancer Institute Partnership Increases Veteran Access to Trials

Thanks to a new partnership between the National Cancer Institute and the VA, veterans with cancer will now have greater access to potentially lifesaving clinical trials.

VA Continues Hepatocellular Screening, but Study Questions the Value

Although a recent study determined that screening veterans with cirrhosis for hepatocellular carcinoma did not reduce the risk of death associated with liver cancer, the VA has no plans to change its screening practices.


U.S. Medicine Recommends


More From oncology

Oncology

VA/National Cancer Institute Partnership Increases Veteran Access to Trials

Thanks to a new partnership between the National Cancer Institute and the VA, veterans with cancer will now have greater access to potentially lifesaving clinical trials.

Oncology

VA Continues Hepatocellular Screening, but Study Questions the Value

Although a recent study determined that screening veterans with cirrhosis for hepatocellular carcinoma did not reduce the risk of death associated with liver cancer, the VA has no plans to change its screening practices.

Oncology

Testosterone Therapy Not Linked to Aggressive Prostate Cancer in Veterans

Clinicians prescribing supplemental testosterone in men with low levels always have a nagging concern about the possible link between increasing hormone levels and prostate cancer.

Oncology

Side-effects Differ Between Radiation Therapies for Prostate Cancer

A recent study compared patient-reported disease-specific functional outcomes after external beam radiation therapy (EBRT) and EBRT combined with low-dose-rate brachytherapy prostate boost (EB-LDR) among men with localized prostate cancer.

Oncology

Parkinson's Drug Not Associated With Higher Prostate Cancer Risk

An increased incidence of prostate cancer was observed in Parkinson's disease (PD) patients treated with entacapone during a pre-approval randomized clinical trial, according to a new study which noted that the relationship had not yet been intensely investigated.

Facebook Comment

Subscribe to U.S. Medicine Print Magazine

U.S. Medicine is mailed free each month to physicians, pharmacists, nurse practitioners, physician assistants and administrators working for Veterans Affairs, Department of Defense and U.S. Public Health Service.

Subscribe Now

Receive Our Email Newsletter

Stay informed about federal medical news, clinical updates and reports on government topics for the federal healthcare professional.

Sign Up