AstraZeneca PLC — Xigduo EMA EPAR public assessment report (EMEA/H/C/002672, 2014)
AstraZeneca PLC · 2014 · EMA EPAR public assessment report · company profile →
Report summary
This EMA EPAR report details the regulatory assessment of Xigduo (dapagliflozin/metformin), a fixed-dose combination for type 2 diabetes. It covers product identification, quality aspects, and manufacturing. Non-clinical studies confirmed no new toxicities, and bioequivalence studies supported the fixed-dose combination. The clinical development program, comprising six Phase III studies, demonstrated Xigduo's efficacy in reducing HbA1c, fasting plasma glucose, and body weight as an add-on to metformin and other antidiabetic drugs. Safety analysis revealed common adverse events like genitourinary infections, consistent with individual components. Ongoing pharmacovigilance and cardiovascular outcome studies are planned. The report concludes with a positive benefit-risk balance, recommending marketing authorization.
Key findings — cited to the page
| Dapagliflozin EU approval date | 12 November 2012 | Forxiga · EU · p.17 |
| Indication wording | Xigduo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin (see sections 4.4, 4.5 and 5.1 for available data on different combinations); or those already being treated with the combination of dapagliflozin and metformin as separate tablets. | Xigduo · p.7 |
| Eligibility to centralised procedure agreed | 15 December 2011 | Xigduo · p.7 |
| Product licensing status at submission | not licensed in any country | Xigduo · Global · p.7 |
| CHMP positive opinion date | 21 November 2013 | Xigduo · p.8 |
| Dapagliflozin marketing authorization date (Forxiga) | 12 November 2012 | Forxiga · p.9 |
| Legal basis for application | Article 10(b) of Directive 2001/83/EC | Xigduo · p.7 |
| Dapagliflozin strengths (Forxiga) | 5 and 10 mg mg | Forxiga · p.9 |
| Dapagliflozin/Metformin fixed dose combinations developed | 2.5/850, 2.5/1000, 5/850 and 5/1000 | Xigduo · p.14 |
| Dapagliflozin/Metformin fixed dose combinations intended for commercial purposes | 5mg/850 mg and 5/1000 mg | Xigduo · p.14 |
| Xigduo strengths | 5mg/850 mg and 5 mg/1000 mg | Xigduo · p.17 |
| Dapagliflozin dose in rat pharmacology studies (normal rats) | 0.1 mg/kg | · p.18 |
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 →