SANOFI-AVENTIS US — Soliqua 100/33 FDA Summary Review (NDA/BLA 208673, 2020)
Sanofi · 2020 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA review of Soliqua 100/33 (insulin glargine/lixisenatide) for type 2 diabetes confirms its efficacy in improving glycemic control. Clinical trials EFC12404 and EFC12405 demonstrated Soliqua's superior HbA1c reduction compared to individual components (Lantus, Adlyxin) in both insulin-naïve patients and those inadequately controlled on basal insulin. While effective, the review notes limitations in dosing flexibility and potential risks like hypoglycemia and gastrointestinal adverse events. Regulatory considerations emphasized demonstrating the contribution of each component, leading to an approved indication as an adjunct to diet and exercise for adults with inadequately controlled type 2 diabetes, presented in a single pen. Concerns regarding product presentation and optimal dosing were also raised.
Key findings — cited to the page
| LS mean treatment difference (HbA1c) | -0.29 % | EFC12404 · p.19 |
| LS mean change in HbA1c from baseline | -0.85 % | EFC12404 · p.19 |
| Endpoint duration | 30 weeks | EFC 12404 · p.17 |
| Number of participants | 234 | EFC 12404 · p.17 |
| LS mean change in HbA1c from baseline | -1.63 % | EFC12404 · p.19 |
| LS mean change in HbA1c from baseline | -1.34 % | EFC12404 · p.19 |
| Allergic reaction events related to investigational product | 0 % | Pooled safety data (ACT12374, EFC12404, EFC12405) · p.26 |
| Trial design | randomized, open-label, multi-center, multi-national, 3 arms, parallel-group, active controlled | EFC 12404 · p.17 |
| Number of participants | 469 | EFC 12404 · p.17 |
| Number of participants | 467 | EFC 12404 · p.17 |
| HbA1c range for eligibility | 7 and 10 % | EFC 12404 · p.17 |
| p-value for superiority (HbA1c) | < 0.0001 | EFC12404 · p.19 |
Source: Sanofi ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →