Suliqua
Metabolic· 797 cited findings· 1 source document
Company: Sanofi →
What the regulatory reviews say
Suliqua (ATC Code A10AE54) is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control. This is for cases where control has not been achieved with metformin alone, metformin combined with another oral glucose-lowering medicinal product, or with basal insulin.
In pivotal Phase III studies lasting 30 weeks, Suliqua demonstrated an LS mean difference in HbA1c (%) of -0.29 compared to insulin glargine. The HbA1c change from baseline was -1.63%. Notable safety findings include nausea (24.0%) and vomiting (6.4%) in Study EFC12404, and diarrhoea (9.0%). Discontinuation due to adverse events was 0.8%. Anti-lixisenatide antibodies were observed in 49.0% of patients in study ACT12374, leading to a 10-fold increase in plasma concentrations of total lixisenatide.
The marketing authorisation application for Suliqua was submitted on 3 March 2016, following eligibility to the centralised procedure agreed by EMA/CHMP on 25 June 2015. The procedure number is EMEA/H/C/004243/0000.
Key figures — cited to the source page
| LS mean difference in HbA1c (%) (FRC - insulin glargine) | -0.29 | Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C, p.72 |
| HbA1c change from baseline (%) | -1.63 | Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C, p.55 |
| Nausea (lixisenatide, Study EFC12404) | 24.0 | Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C, p.109 |
| Vomiting (lixisenatide, Study EFC12404) | 6.4 | Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C, p.109 |
| Diarrhoea (Study EFC12404) | 9.0 | Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C, p.109 |
| Percentage of patients with anti-lixisenatide antibodies in ACT12374 | 49.0 | Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C, p.33 |
| IMP discontinuation due to AEs | 0.8 | Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C, p.62 |
| Marketing authorisation application submission date | 3 March 2016 | Sanofi — Suliqua EMA EPAR public assessment report (EMEA/H/C, p.6 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.