Forxiga(dapagliflozin)
Metabolic· 1142 cited findings· 1 source document
Company: AstraZeneca PLC →
What the regulatory reviews say
Forxiga (dapagliflozin) is a drug indicated for the treatment of type 2 diabetes mellitus. Regulatory review documents detail its efficacy in reducing HbA1c levels, with a change from baseline of -0.72%. The absolute bioavailability of dapagliflozin is reported as 78%.
Safety findings indicate that 3.5% of subjects experienced at least one hypoglycaemia event. Discontinuation due to lack of glycaemic control was observed in 0.3% of subjects.
Regulatory milestones include the CHMP positive opinion for Marketing Authorisation on 19 April 2012, with a revised opinion on 18 September 2012. The procedure start date was 19 January 2011.
Key figures — cited to the source page
| HbA1c change from baseline | -0.72 | AstraZeneca PLC — Forxiga EMA EPAR public assessment report, p.63 |
| Absolute bioavailability of dapagliflozin | 78 | AstraZeneca PLC — Forxiga EMA EPAR public assessment report, p.38 |
| Subjects with at least one hypoglycaemia event | 3.5 | AstraZeneca PLC — Forxiga EMA EPAR public assessment report, p.87 |
| Discontinuation due to lack of glycaemic control | 0.3 | AstraZeneca PLC — Forxiga EMA EPAR public assessment report, p.87 |
| CHMP positive opinion for Marketing Authorisation | 19 April 2012 | AstraZeneca PLC — Forxiga EMA EPAR public assessment report, p.8 |
| Revised CHMP positive opinion for Marketing Authorisation | 18 September 2012 | AstraZeneca PLC — Forxiga EMA EPAR public assessment report, p.8 |
| Procedure start date | 19 January 2011 | AstraZeneca PLC — Forxiga EMA EPAR public assessment report, p.7 |
| Number of pivotal Phase 3 studies | 7 | AstraZeneca PLC — Forxiga EMA EPAR public assessment report, p.10 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.