Source: Pharmaceutical Technology
Trial results showed a significant decrease in A1C for patients treated with Farxiga versus those given a placebo. Credit: Studio Romantic / Shutterstock. Recommended Buyer's Guides
Source: Pharmaceutical Technology
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The approval is a significant milestone, expanding the medication’s use to improve glycaemic control in children beyond its previous adult-only indication.
The FDA’s decision was based on the randomised, double-blind, placebo-controlled T2NOW Phase III trial. The study assessed the efficacy and safety of dapagliflozin as an additional treatment for children and adolescents already taking metformin, insulin or both. See Also:Takeda signs option agreement with Ascentage for CML drug Source: Pharmaceutical Technology
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Source: Pharmaceutical Technology
The trial’s primary goal was to observe the change in A1C (haemoglobin) levels after 26 weeks compared to placebo for both dapagliflozin and saxagliptin. Secondary objectives included monitoring fasting plasma glucose levels and the percentage of patients achieving an A1C level below 7%.
Trial results showed a significant decrease in A1C for patients treated with Farxiga versus those given a placebo. The adjusted mean change in A1C was -0.62% for Farxiga compared to +0.41% for the placebo group. Farxiga demonstrated a clinically meaningful improvement in glycaemic control for children and adolescents with T2D. The asset has also been approved for paediatric patients aged 10 years and above with T2D in 56 countries, based on the T2GO Phase III trial. Further regulatory submissions and market evaluations are underway to determine additional rollout plans.