The US Food and Drug Administration (FDA) has granted regulatory approval to AstraZeneca (AZ; NASDAQ: AZN) for its SGLT2 inhibitor, Farxiga (dapagliflozin), expanding its use to pediatric patients aged 10 and above with type-2 diabetes (T2D). This approval supplements the drug’s original indication for adult patients.
The FDA’s decision was informed by Phase III clinical trial data, which demonstrated that Farxiga significantly reduced the average blood sugar marker A1C by 1.03% compared to a placebo. The safety profile of the drug in pediatric patients was found to be consistent with that observed in adult populations.- Flcube.com
