US FDA approves AstraZeneca's Farxiga to treat type 2 diabetes

Reversing a previous 2012 negative decision, the US Food and Drug Administration yesterday (January 8) approved Anglo-Swedish drug major’s AstraZeneca’s (LSE: AZN) dapagliflozin, (proposed US trade name Farxiga), to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Dapagliflozin, an SGLT2 inhibitor to which AstraZeneca is gaining full rights under its recent diabetes assets deal with partner Bristol-Myers Squibb (NYSE: BMY; The Pharma Letter December 20, 2013), is already approved in the 28 member states of the European Union, where it carries the brand name Forxiga, and in Argentina, Australia, Brazil, Iceland, Mexico.

Decision follows recent advisory panel backing