Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C/004243, 2017)
Sanofi · 2017 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the administrative and scientific assessment of Suliqua (insulin glargine/lixisenatide), a fixed-ratio combination for type 2 diabetes. It details the product's quality, non-clinical studies, and clinical pharmacology, including pharmacokinetics, pharmacodynamics, and drug interactions. Pivotal Phase 3 studies (EFC12404, EFC12405) demonstrated Suliqua's superior efficacy in reducing HbA1c and postprandial glucose, with favorable body weight changes, compared to its individual components. The safety profile showed comparable overall adverse events to insulin glargine, fewer GI events than lixisenatide monotherapy, and similar hypoglycemia rates to insulin glargine. The report concludes that Suliqua's quality, safety, and efficacy are acceptable for its intended use.
Key findings — cited to the page
| Maximum reduction in glucose production rate | 44 % | · p.37 |
| EC50 for glucose production rate | 18.5 pg/mL | · p.37 |
| Vomiting (insulin glargine, Phase 3 study pool) | 1.1 % | · p.109 |
| Applicant | sanofi-aventis groupe | Suliqua · p.2 |
| ATC Code | A10AE54 | Suliqua · p.2 |
| FPG | -0.46 mmol/L | Study EFC12405 · p.75 |
| Strength (insulin glargine / lixisenatide) | 100 U/ml / 33 µg/ml | Suliqua · p.2 |
| Therapeutic indication | Suliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin | Suliqua · p.2 |
| Strength (insulin glargine / lixisenatide) | 100 U/ml / 50 µg/ml | Suliqua · p.2 |
| Marketing authorisation application submission date | 3 March 2016 | Suliqua · p.6 |
| Eligibility to centralised procedure agreed by EMA/CHMP | 25 June 2015 | Suliqua · p.6 |
| Procedure Number | EMEA/H/C/004243/0000 | Suliqua · p.1 |
Source: Sanofi ↗ · 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 →