FDA Approves Farxiga to Treat Type 2 Diabetes

The US Food and Drug Administration has approved Farxiga (dapaglifozin) as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The agent is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lower blood glucose levels.
Diabetes information with medication in the background"Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treat-ment 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.

Approval of Farxiga was based on a review of 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c levels. The agent has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, pioglitazone, glimepiride, sitagliptin, and insulin.

Farxiga is the second SGLT2 agent to be approved by the FDA. The first agent, Invokana (canagliflozin) was approved in March, 2013. As with Invokana, Farxiga should not be used to treat people with type 1 diabetes or patients with diabetic ketoacidosis; or those with mod-erate or severe renal impairment, end stage renal disease, or patients on dialysis. Adverse effects of Farxiga include dehydration, leading to hypotension. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk, noted a press release from the FDA. In clinical trials the most common side effects observed in patients treated with Farxiga were genital mycotic (fungal) infections and urinary tract infections.

Cancer Concern
An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials. Therefore, Farxiga is not recommended for patients with active bladder cancer. According to the FDA, "Patients with a history of bladder cancer should talk to their physician before using Farxiga."

The FDA is requiring six post-marketing studies for Farxiga: • a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of car-diovascular disease; • a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT; • an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents; • two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and • an enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.

Farxiga is marketed by Bristol-Meyers Squibb Company, Princeton, New Jersey and AstraZeneca Pharmaceuticals, Wilmington, Deleware.

Based on a press release from the US Food and Drug Administration.

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