AZ’s Combination Diabetes Pill Wins U.S. Approval

AstraZeneca said it plans to launch its new two-in-one diabetes pill Xigduo XR early next year in the U.S. after winning FDA approval last week.

The once-daily drug, which combines dapagliflozin and metformin HCl, is indicated with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. It is the first and only drug of its kind approved in the U.S., AZ said.

Xigduo XR already is approved in Australia, and Xigduo, which uses an immediate-release form of metformin, is approved in the European Union, the company added.

Dapagliflozin, known as Farxiga in the U.S., was jointly developed with Bristol-Myers Squibb. It was approved in early January, a month after AZ said it was buying BMS’s share of their diabetes partnership.

The combination pill contains a boxed warning for lactic acidosis, a rare but serious complication brought on when the body’s cells don’t receive enough oxygen. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.