AstraZeneca PLC — Edistride EMA EPAR public assessment report (EMEA/H/C/004161, 2015)
AstraZeneca PLC · 2015 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for Edistride (dapagliflozin) for type 2 diabetes mellitus, based on a positive opinion from the CHMP. Edistride is an informed consent application referencing the previously authorized Forxiga. The assessment confirmed the established efficacy and safety profile of dapagliflozin. Key safety concerns addressed include renal function issues, volume depletion in elderly patients, and potential malignancy risks. Risk minimization measures and recommendations for use in specific populations (elderly, pediatric, pregnant/nursing, renal/hepatic impairment) were outlined. Ultimately, the CHMP concluded that Edistride demonstrated a favorable benefit-risk balance.
Key findings — cited to the page
| Forxiga Community Marketing Authorisation date | 12 November 2012 | Forxiga · p.3 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 26 February 2015 | · p.3 |
| Marketing Authorisation application submission date | 3 July 2015 | Edistride · p.3 |
| CHMP positive opinion for Marketing Authorisation | 24 September 2015 | Edistride · p.4 |
| Adverse reactions of volume depletion in subjects ≥ 65 years (placebo) | 0.8 % | · p.24 |
| Proportion of subjects with malignant or unspecified tumours (dapagliflozin) | 1.50 % | · p.20 |
| Adverse reactions related to renal impairment or failure in subjects ≥ 65 years (dapagliflozin) | 7.7 % | · p.24 |
| Proportion of subjects with malignant or unspecified tumours (placebo/comparator) | 1.50 % | · p.20 |
| Adverse reactions related to renal impairment or failure in subjects ≥ 65 years (placebo) | 3.8 % | · p.24 |
| Adverse reactions of volume depletion in subjects ≥ 65 years (dapagliflozin) | 1.7 % | · p.24 |
| Major hypoglycaemia incidence (dapagliflozin 10 mg + insulin) | 1.0 % | · p.14 |
| Minor hypoglycaemia incidence (placebo + insulin) | 41.6 % | · p.14 |
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 →