Takeda Pharmaceutical Company Limited — Incresync EMA EPAR public assessment report (EMEA/H/C/002178, 2013)
Takeda Pharmaceutical Company Limited · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's CHMP assessment report details the regulatory approval of Incresync (alogliptin/pioglitazone), a fixed-dose combination for type 2 diabetes. It covers the product's quality, manufacturing, and non-clinical aspects, including pharmacodynamics, pharmacokinetics, and toxicology of both active substances individually and in combination. Clinical trials demonstrated significant HbA1c reductions and non-inferiority/superiority in efficacy. The safety profile, while generally acceptable, notes common adverse events like nasopharyngitis and peripheral edema, and addresses specific concerns such as cardiovascular events, pancreatitis, and hypoglycemia risk, particularly in combination therapies. The report concludes with the benefit-risk balance supporting marketing authorization.
Key findings — cited to the page
| Marketing Authorisation in US | 25 January 2013 | Incresync · United States · p.8 |
| hPPARγ1 EC50 | 420 nmol/L | pioglitazone · p.20 |
| Phase | III | Study 322OPI-004 · p.84 |
| Duration of Main phase | 52 weeks | Study 322OPI-004 · p.84 |
| Duration of Run-in phase | 4 weeks | Study 322OPI-004 · p.84 |
| Pioglitazone 5-year renewals received European Commission decisions | August 2010 | pioglitazone · p.19 |
| DPP-4 inhibition IC50 | 6.9 nmol/L | alogliptin · p.20 |
| DPP-4 inhibition IC50 | 23.8 nmol/L | vildagliptin · p.20 |
| DPP-4 inhibition IC50 | 12.1 nmol/L | sitagliptin · p.20 |
| Plasma glucose AUC(0-90min) decrease | 75 % of control | alogliptin · p.20 |
| Plasma insulin levels increase | 146 % of control | alogliptin · p.20 |
| hPPARγ1 EC50 | 490 nmol/L | pioglitazone · p.20 |
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 →