AstraZeneca PLC — Forxiga EMA EPAR public assessment report (EMEA/H/C/002322, 2012)
AstraZeneca PLC · 2012 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Forxiga (dapagliflozin) for type 2 diabetes mellitus involved extensive clinical and non-clinical studies. Quality aspects of the drug substance and product were thoroughly reviewed. Pharmacokinetic and pharmacodynamic modeling informed dose selection for Phase III trials. Efficacy studies consistently demonstrated significant reductions in HbA1c, fasting plasma glucose, and body weight across various monotherapy and add-on regimens, showing non-inferiority to glipizide with fewer hypoglycemic events. Efficacy was dose-dependent but diminished with declining renal function. Safety concerns included increased risks of genital/urinary tract infections, volume depletion, and hypoglycemia (with insulin/SU). While initial cancer imbalances were noted, later data and non-clinical evidence did not support a causal link, though post-marketing surveillance was recommended. The overall benefit-risk balance was deemed positive, leading to marketing authorization, with specific recommendations for patient selection and risk management, particularly for elderly and renally impaired patients.
Key findings — cited to the page
| NOEC for Daphnia sp. Reproduction Test | 10000 µg/L | · p.31 |
| Number of pivotal Phase 3 studies | 7 | · p.10 |
| Revised CHMP positive opinion for Marketing Authorisation | 24 May 2012 | Forxiga · Europe · p.8 |
| Scientific Advice from CHMP | 18-21 February 2008 | Europe · p.7 |
| Number of Phase 3 studies | 11 | · p.10 |
| CHMP positive opinion for Marketing Authorisation | 19 April 2012 | Forxiga · Europe · p.8 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 22 April 2010 | Europe · p.6 |
| Revised CHMP positive opinion for Marketing Authorisation | 21 June 2012 | Forxiga · Europe · p.8 |
| Revised CHMP Assessment Report finalised by written procedure | 5 July 2012 | Europe · p.8 |
| Revised CHMP positive opinion for Marketing Authorisation | 18 September 2012 | Forxiga · Europe · p.8 |
| Procedure start date | 19 January 2011 | Europe · p.7 |
| HbA1c change from baseline | -0.72 % | MB102032 · p.63 |
Source: AstraZeneca PLC ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →