FDA Expands AstraZeneca's (AZN) Farxiga Label in Pediatric T2D [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
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Source: Yahoo! Finance
Farxiga is now approved as an adjunct to diet and exercise to improve glycemic control in individuals aged 10 years and older with T2D. Prior to this label expansion, the drug was approved for improving glycemic control in adults with T2D. This latest approval is based on data from the phase III T2NOW study that evaluated the efficacy and safety of Farxiga as an add-on treatment in children and adolescents with T2D. The study achieved its primary endpoint — treatment with Farxiga achieved a significant reduction in A1C (a marker of average blood sugar) after 26 weeks of treatment when compared to the placebo. An oral SGLT2 inhibitor, Farxiga is already approved by the FDA for heart failure (HF) and chronic kidney disease (CKD) indications in adults. AstraZeneca's shares have risen 18.9% year to date compared with the industry's 20.1% growth. Image Source: Zacks Investment Research Such label expansions are likely to help boost AstraZeneca's top line, which has been experien
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