- The approval is based on P-III two DEPICT study results DEPICT 1 (NCT02268214) & DEPICT 2 (NCT02460978) assessing Forxiga (5/10 mg) vs PBO in patients with T1D inadequately controlled by insulin for 24 to 52 wks.
- The study resulted in meeting its 1EPs & 2EPs as reductions in average blood glucose levels HbA1c weight and total daily insulin dose for 24 & 52 wks. demonstrating safe and effective results
- Forxiga (dapagliflozinm, qd, PO) is a novel inhibitor of human sodium-glucose co-transporter 2 (SGLT2) and is currently under review in Japan & the US as an adjunct treatment to insulin in adults with T1D with expected approval in Q1’19 and Q2’19 respectively
Click here to read full press release/ article | Ref: AstraZeneca| Image: WSJ