Insulin glargin / Lixisenatid (2) – Suliqua®
Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors
Characteristics
| Start date | 15.04.2020 – Marketing authorisation: 09.03.2020 |
|---|---|
| Resolution | 15.10.2020 |
| INN | Insulin glargin/Lixisenatid |
| Brand name | Suliqua® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-539 |
| ATC code | A10AE54 Insulins and analogues for injection, long-acting (A10AE) |
| DDD | 40 U P |
| Therapeutic area | Metabolic diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
- Clinical trials
- The G-BA has reached its decision on whether an additional benefit of insulin glargine/lixisenatide can be established compared with the appropriate comparator therapy, based on the dossier submitted by the pharmaceutical manufacturer, the dossier assessment prepared by the IQWiG, and the statements presented during the written and oral consultation procedures.
a) Adult patients with type 2 diabetes mellitus whose condition is not adequately controlled by treatment with at least two blood glucose-lowering medicinal products (excluding insulin)
- An additional benefit is not proven.
b) Adult patients with type 2 diabetes mellitus whose condition is not adequately controlled by treatment with insulin (with or without another blood glucose-lowering medicinal product)
- An additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Insulin glargin / Lixisenatid (2) | Suliqua® | Sanofi-Aventis Deutschland GmbH | Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors | 532,000 | 100% additional benefit not proven | |
| Insulin glargin / Lixisenatid (1) | Suliqua® | Sanofi-Aventis Deutschland GmbH | Diabetes mellitus type 2 | 461,400–472,500 | 100% additional benefit not proven |
<< List of all resolutions