News Feature | January 10, 2014

New Diabetes Drug Approved By The FDA

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By Cyndi Root

Diabetes has a new nemesis, a drug called Farxiga, which eliminates excess sugar through the urine. Adults with type 2 diabetes have a new treatment option with the Food and Drug Administration (FDA) approval. Millions of people have another option, which works by a different mechanism than existing therapies. Treating diabetes with effective strategies is critical as serious complications can result from high blood sugar. Astra Zeneca and Bristol-Meyers Squibs co-market the medicine.

Curtis Rosebraugh, M.D., M.P.H., director in the FDA’s Center for Drug Evaluation and Research said, “Controlling blood sugar levels is very important in the overall treatment and care of diabetes.”  Farxiga (dapagliflozin) is taken by tablet orally once a day. It works by itself or in combination with other diabetes drugs.

Type 2 Diabetes Mellitus

Type 2 diabetes mellitus is prevalent in the U.S. with over 24 million people afflicted. 90 percent of all diabetes cases are type 2. Untreated or poorly managed diabetes results in high blood sugar levels. Over time, these high or fluctuating blood sugar levels increase the risks for heart disease, nerve damage, and blindness among other serious consequences.

Farxiga and SGLT2 Inhibitors

Farxiga is in a new class of drugs, called SGLT2 drugs. It is the second one approved by the FDA, preceded by Invokana by Johnson & Johnson. Existing diabetes therapies target insulin resistance, delaying digestion, and supplying external sources of insulin. SGLT2 inhibitors work by inhibiting glucose absorption in the renal tubes, eliminating excess sugar via the urine.

Some patients who used Farxiga in the clinical trials experienced side effects of urinary tract infections and genital fungal infections. Some patients developed bladder cancer, which originally caused the FDA to reject the drug. The agency concluded that the bladder cancer rates might be a statistical fluke but people with bladder cancer should not use it. The FDA has stipulated that a post-marketing study be conducted by Astra Zeneca and Bristol-Myers to track bladder cancer rates. Five other studies are required.

  • human patients with a high risk of cardiovascular disease
  • animal studies measuring urinary flow rate
  • two clinical trials on children will measure the efficacy and safety of the drug
  • pharmacovigilence programs will track liver abnormalities and monitor the effects on pregnancy