Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR public assessment report (EMEA/H/C/002654, 2013)
Takeda Pharmaceutical Company Limited · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The CHMP granted marketing authorization for Vipdomet (alogliptin/metformin), a fixed-dose combination for type 2 diabetes, based on a positive benefit-risk assessment. The report details the product's quality, manufacturing, and non-clinical pharmacology, pharmacokinetics, and toxicology. Clinical studies demonstrated Vipdomet's efficacy in reducing HbA1c, both as monotherapy and in combination with other antidiabetic agents. Safety data indicated a generally low incidence of severe adverse events, though pancreatitis and pancreatic cancer were identified as risks, leading to their inclusion in the Risk Management Plan. The report also covers pharmacokinetics, pharmacodynamics, and safety in special populations, concluding an acceptable environmental risk.
Key findings — cited to the page
| Alogliptin NOEC Daphnia sp. Reproduction Test | 10 µg/L | · p.40 |
| Withdrawn application for alogliptin/metformin strengths | 6.25 mg+850 mg, 6.25 mg+1000 mg | · p.50 |
| Subjects from US or Canada | 33 % | United States, Canada · p.104 |
| Alogliptin tablet strengths developed | 3.125, 6.25, 12.5, and 25 mg | · p.50 |
| Alogliptin dose strength for moderate renal impairment | 12.5 mg | · p.50 |
| Alogliptin tablet strength not being sought for registration | 3.125 mg | · p.50 |
| Alogliptin dose strength proposed for severe renal impairment/ESRD | 6.25 mg | · p.50 |
| Marketing Authorisation date | 25 January 2013 | Vipdomet · United States · p.7 |
| Marketing Authorisation Application submission date | 30 May 2012 | Vipdomet · EU · p.6 |
| CL/F range for alogliptin | 15-20 L/hr | · p.51 |
| CHMP positive opinion date | 25 July 2013 | Vipdomet · EU · p.8 |
| Absolute bioavailability of alogliptin | close to 100 % | · p.50 |
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 →