Diabetes Rx One Step Closer to Approval

Canagliflozin for type 2 diabetes recommended for approval by FDA advisory committee

(RxWiki News) When diet and exercise aren't enough to control blood sugar levels, diabetes patients may need to take medications. Now, diabetes patients may be closer to having one more medication option.

An advisory committee of the FDA has voted 10-5 to recommend approval of canagliflozin to treat type 2 diabetes.

To make their decision, experts on the committee looked at findings from a large clinical trial testing the safety and effectiveness of canagliflozin. Results showed that the medication was able to lower blood sugar levels but may raise the risk of heart, kidney and bone-related problems. Despite these possible risks, the committee has recommended approval of canagliflozin.

"Ask your doctor about emerging treatment options for your disease."

"We are pleased with the positive recommendation from the committee and look forward to working with the FDA to bring this important new therapy to patients in the US to help them manage their type 2 diabetes,” said Peter Stein, MD, Head, Metabolism Development, Diabetes Disease Area Leader, Janssen. "Today’s outcome represents an important step toward achieving that goal."

Canagliflozin is part of a new class of medications called subtype 2 sodium-glucose transport protein (SGLT2) inhibitors. These medications lower blood sugar by increasing the amount of sugar that is excreted through urine.

A year ago, the FDA rejected a similar medication by AstraZeneca and Bristol-Myers Squibb. The medication - called dapagliflozin - was rejected in the US over safety concerns. However, it has been approved in Europe.

If the FDA approves canagliflozin later this year, it will be marketed by Janssen Pharmaceuticals under the trade name Invokana. The medication could become the first SGLT2 inhibitor available to American diabetes patients.

The data presented to committee members came from a Phase 3 clinical program that included 10,285 patients in nine studies. Canagliflozin was tested at 100 mg and 300 mg once-daily doses and compared to placebo (sugar pill) and other diabetes medications. In addition, canagliflozin was tested in older patients, patients with moderate kidney damage and patients who had or were at risk of heart disease.

Results showed that canagliflozin treatment led to improved blood sugar control and was linked to weight loss and reduced blood pressure. However, the medication was also associated with heart, kidney and bone-related complications as well as certain types of infection.

Now, the FDA will consider the advisory committee's recommendation. While the FDA is not required to follow the recommendation, it usually does.

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Review Date: 
January 10, 2013