Boehringer Ingelheim — Trajenta EMA EPAR public assessment report (EMEA/H/C/002110, 2011)
Boehringer Ingelheim · 2011 · EMA EPAR public assessment report
Report summary
The European Medicines Agency (EMA) assessed Trajenta (linagliptin) for marketing authorization for type 2 diabetes mellitus. Linagliptin, a selective DPP-4 inhibitor, demonstrated significant HbA1c and FPG reductions as monotherapy and in combination with metformin or sulfonylurea. Its 5 mg dose was optimal, and it proved suitable for patients with renal impairment. Pharmacokinetic studies detailed its absorption, distribution, and elimination, with no significant drug interactions. Safety data showed comparable adverse event rates to placebo, though hypoglycemia was more frequent, especially with sulfonylurea. Linagliptin generally had a weight-neutral effect, except with pioglitazone, and did not increase cardiovascular risk. While effective across subgroups, some uncertainties remain regarding long-term safety and specific populations.
Key findings — cited to the page
| NOEC for Daphnia sp. Reproduction Test | 3.2 mg/L | · p.18 |
| Linagliptin IC50 for human DPP-4 | 0.20 nM | linagliptin · p.10 |
| Scientific Advice date (clinical aspects) | 19 July 2007 | Trajenta (linagliptin) · p.4 |
| US Marketing Authorisation date | 2 May 2011 | Trajenta (linagliptin) · United States · p.4 |
| Marketing Authorisation application submission date | 30 June 2010 | Trajenta (linagliptin) · Europe · p.3 |
| EMA/CHMP eligibility agreement date | 19 March 2009 | Trajenta (linagliptin) · Europe · p.3 |
| Linagliptin IC50 for human DPP-4 | 1 nM | linagliptin · p.5 |
| Scientific Advice date (clinical aspects) | 23 April 2008 | Trajenta (linagliptin) · p.4 |
| Linagliptin IC50 for cynomolgus DPP4 | 0.23 nM | linagliptin · p.10 |
| CHMP positive opinion date | 23 June 2011 | Trajenta (linagliptin) · Europe · p.4 |
| Linagliptin therapeutic dose | 5 mg | linagliptin · p.5 |
| Linagliptin oral bioavailability in mice | 18-44 % | linagliptin · p.11 |
Source: Boehringer Ingelheim ↗ · 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 →