Shots:

• The approval is based on P-III DEPICT & D1695C00001 study results assessing Forxiga (5/10 mg) vs PBO in patients with T1D inadequately controlled by insulin for 28 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 wks.
• Forxiga (dapagliflozinm- qd- PO) is a novel inhibitor of human sodium-glucose co-transporter 2 (SGLT2) approved by European Commission on Mar 20- 2019 and is currently under review by the US FDA as an adjunct treatment to insulin in adults with expected results in H2’19

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