AstraZeneca PLC — Ebymect EMA EPAR public assessment report (EMEA/H/C/004162, 2015)
AstraZeneca PLC · 2015 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted a positive marketing authorization opinion for AstraZeneca's Ebymect (dapagliflozin/metformin) for type 2 diabetes. This informed consent application leveraged data from the previously approved Xigduo, a duplicate product. The assessment confirmed Ebymect's mechanism of action, clinical efficacy, and safety profile, which includes a comprehensive risk management plan. Safety concerns, inherited from Xigduo, involve volume depletion and hematocrit changes. Contraindications and warnings apply to renal/hepatic impairment, cardiac issues, and specific populations (elderly over 75, pediatric, pregnant/nursing). Despite these, the overall benefit-risk balance for Ebymect in type 2 diabetes was deemed favorable.
Key findings — cited to the page
| Eligibility to centralised procedure agreed date | 26 February 2015 | Ebymect · Europe · p.3 |
| Legal basis for application | Article 10(c) of Directive 2001/83/EC | Ebymect · Europe · p.3 |
| Community Marketing Authorisation date for Xigduo | 16 January 2014 | Xigduo · Europe · p.3 |
| Procedure start date | 27 July 2015 | Ebymect · p.4 |
| CHMP positive opinion date for Marketing Authorisation | 24 September 2015 | Ebymect · p.4 |
| Hypoglycaemia rate (minor episodes) with dapagliflozin 10 mg + metformin | 6.9 % | · p.15 |
| Hypoglycaemia rate (minor episodes) with placebo + metformin | 5.5 % | · p.15 |
| Major hypoglycaemia rate with dapagliflozin 10 mg + insulin at Week 24 | 0.5 % | · p.16 |
| Major hypoglycaemia rate with dapagliflozin 10 mg + insulin at Week 104 | 1.0 % | · p.16 |
| Major hypoglycaemia rate with placebo + insulin at Week 24 | 0.5 % | · p.16 |
| Major hypoglycaemia rate with placebo + insulin at Week 104 | 0.5 % | · p.16 |
| Marketing Authorisation application submission date | 3 July 2015 | Ebymect · Europe · p.3 |
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 →