Takeda Pharmaceutical Company Limited — Vipidia EMA EPAR public assessment report (EMEA/H/C/002182, 2013)
Takeda Pharmaceutical Company Limited · 2013 · EMA EPAR public assessment report · company profile →
Report summary
This EMA EPAR summarizes the assessment of Vipidia (alogliptin) for marketing authorization in type 2 diabetes. It details the drug's quality, non-clinical pharmacology, toxicology, and clinical efficacy and safety. Alogliptin, a DPP-4 inhibitor, consistently demonstrated significant HbA1c and FPG reductions as monotherapy or add-on therapy in Phase III trials. The safety profile showed it was generally well-tolerated, with a low risk of hepatic toxicity and weight neutrality. Concerns regarding rare hepatotoxicity, pancreatitis, and hypersensitivity reactions are addressed in the Risk Management Plan. The CHMP recommended marketing authorization, citing modest but clinically relevant efficacy comparable to other DPP-4 inhibitors.
Key findings — cited to the page
| NOEC for Daphnia sp. Reproduction Test with alogliptin | 10 µg/L | · p.26 |
| Marketing Authorisation in US | 25 January 2013 | Vipidia · United States · p.6 |
| Marketing Authorisation in Mexico | 29 August 2012 | Vipidia · Mexico · p.6 |
| FPG LS mean difference (A12.5 vs Placebo) | -1.199 | Study 010 · p.54 |
| FPG LS mean difference (A25 vs Placebo) | -1.541 | Study 010 · p.54 |
| Body weight change (LS mean) | 0.18 | Study 010 (Placebo) · p.54 |
| FPG change from baseline (LS mean) | -0.913 | Study 010 (A25) · p.54 |
| Marketing Authorisation in Korea | 31 May 2013 | Vipidia · Korea · p.6 |
| Marketing Authorisation in China | 16 July 2013 | Vipidia · China · p.6 |
| CHMP positive opinion for Marketing Authorisation | 25 July 2013 | Vipidia · Europe · p.7 |
| Alogliptin and alogliptin/pioglitazone FDC first approved in Japan | April 2010 | Alogliptin and alogliptin/pioglitazone FDC · Japan · p.8 |
| Subjects from US or Canada | 33 % | United States, Canada · p.75 |
Source: Takeda Pharmaceutical Company Limited ↗ · 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 →