AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Type-1 Diabetes (T1D) in Japan

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

Click here to read full press release/ article | Ref: Astrazeneca | Image: AstraZeneca US