AstraZeneca’s Farxiga (Dapagliflozin) Bags the US FDA’s Approval to Treat Type-2 Diabetes in Pediatric Patients
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- The US FDA has approved Farxiga to treat pediatric patients (≥10yrs.) with T2D, supported by the P-III (T2NOW) study. It is already approved for T2D adults as an adjunct to diet & exercise
- The P-III (T2NOW) study assesses the safety & efficacy of Farxiga (5mg/10mg) vs PBO as an add-on therapy in T2D children & adolescents on metformin, insulin or both
- The results, published in the NEJM, depicted reduced A1C levels with Farxiga vs PBO with an adjusted mean change in A1C of -0.62% vs +0.41% (difference: -1.03%). The study further met 1EPs & 2EPs at wk.26, showing improved glycemia. Further regulatory submissions & rollout plans are being considered; contingent upon market evaluations
Ref: AstraZeneca | Image: AstraZeneca
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
