AZ scores FDA approval of once-daily diabetes fixed-dose combo pill
- The FDA has approved AstraZeneca's Xigduo XR, a once-daily oral tablet for the treatment of type 2 diabetes in adults.
- Xigduo XR is the first once-daily fixed-dose combination of an SGLT2 inhibitor (Farxiga/dapagliflozin) and metformin to win FDA approval.
- The drug is not recommended for type 1 diabetes patients, or for patients with diabetic ketoacidosis.
AZ execs were bullish on the newest addition to the pharma giant's impressive diabetes franchise. “The addition of XIGDUO XR to our U.S. diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes,” said Elisabeth Björk, Head of Cardiovascular & Metabolism in AZ's Global Medicines Development department.
“The approval of once-daily XIGDUO XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.”
The ease of the once-daily tablet formulation immediately makes the drug a blockbuster contender—but the diabetes field is a crowded one, as some company executives have come to learn the hard way.