Eli Lilly and Company — Trulicity EMA EPAR variation assessment report (EMEA/H/C/002825, 2014)
Eli Lilly and Company · 2014 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the Type II variation assessment for Trulicity (dulaglutide) to include children and adolescents (10 to <18 years) with type 2 diabetes. Non-clinical data showed no specific pediatric safety concerns. Clinical pharmacology confirmed adult doses (0.75 mg and 1.5 mg once weekly) are appropriate, demonstrating dose-related glycemic control. The Phase 3 GBGC study showed significant HbA1c and FBG improvements over placebo, sustained for 52 weeks, though no BMI effect. The safety profile was consistent with adults, with common gastrointestinal adverse events and no severe hypoglycemia. The application included updates to product information and the Risk Management Plan.
Key findings — cited to the page
| NOAEL for liraglutide neoplastic lesions | < 0.5 fold safety margin | · p.12 |
| Initial marketing authorization date in US | 18 Sept 2014 | Trulicity · United States · p.9 |
| Number of randomized patients | 154 | GBGC · United States, Mexico, Brazil, Germany, France, United Kingdom, Türkiye, India, Saudi Arabia · p.35 |
| Number of centers | 46 | GBGC · United States, Mexico, Brazil, Germany, France, United Kingdom, Türkiye, India, Saudi Arabia · p.35 |
| Allergic/Hypersensitivity Reaction TEAEs (Dula 0.75 mg) | 5.9 % | · p.47 |
| Liraglutide binding affinity to GLP-1 receptor (IC50, with 2% albumin) | 18 nM | · p.11 |
| Dulaglutide agonist activity (EC50) | 12.5 pM | · p.12 |
| Native GLP-1 cAMP accumulation (EC50) | 1 to 2 pM | · p.12 |
| Liraglutide cAMP accumulation (EC50, similar assay) | 61.0 pM | · p.12 |
| Native GLP-1 cAMP accumulation (EC50, similar assay) | 55 pM | · p.12 |
| NOAEL for dulaglutide tumorigenicity | 0.5 fold safety margin | · p.12 |
| Dulaglutide C-cell carcinomas exposure | 58 fold the human plasma exposure | · p.12 |
Source: Eli Lilly and Company ↗ · 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 →