Synjardy
Metabolic· 1015 cited findings· 3 source documents
Company: Boehringer Ingelheim
What the regulatory reviews say
SYNJARDY is a New Combination NDA submitted by Boehringer Ingelheim for the indication of adjunct to diet and exercise to improve glycemic control in adult subjects with type 2 diabetes mellitus. The FDA recommended approval for this application (NDA-206111) with a PDUFA Goal Date of June 4, 2015. The proposed dosing regimens are 5/500 mg, 5/1000 mg, 12.5/500 mg, and 12.5/1000 mg.
Efficacy and safety data were evaluated over a duration of 52 weeks. In studies, empagliflozin pooled demonstrated a change from baseline in HbA1c of -0.84% versus placebo (p-value 0.0116). For linagliptin 5 mg, the change from baseline in HbA1c versus placebo was -0.34% (p-value 0.2935). When empagliflozin 10 mg was titrated to 10 mg, the placebo-adjusted mean change from baseline in HbA1c was -1.18% (nominal p-value 0.0015).
Regarding safety, premature discontinuation of the trial drug in the empagliflozin pooled group was 15.4%. Non-compliance with trial drug intake in the empagliflozin pooled group was 5.8%. Patients initiating glycaemic rescue therapy in the empagliflozin pooled group was 9.6%.
Key figures — cited to the source page
| Change from baseline in HbA1c for empagliflozin pooled vs placebo | -0.84 | Boehringer Ingelheim — Synjardy EMA EPAR variation assessmen, p.27 |
| p-value for change from baseline in HbA1c for empagliflozin pooled vs placebo | 0.0116 | Boehringer Ingelheim — Synjardy EMA EPAR variation assessmen, p.27 |
| Placebo-adjusted mean change from baseline in HbA1c for empagliflozin 10+titr 10 | -1.18 | Boehringer Ingelheim — Synjardy EMA EPAR variation assessmen, p.27 |
| Nominal p-value for HbA1c reduction for empagliflozin 10+titr 10 | 0.0015 | Boehringer Ingelheim — Synjardy EMA EPAR variation assessmen, p.27 |
| Premature discontinuation of trial drug in empagliflozin pooled group | 15.4 | Boehringer Ingelheim — Synjardy EMA EPAR variation assessmen, p.24 |
| Patients initiating glycaemic rescue therapy in empagliflozin pooled group | 9.6 | Boehringer Ingelheim — Synjardy EMA EPAR variation assessmen, p.32 |
| Recommendation on Regulatory Action | approval | Boehringer Ingelheim — Synjardy FDA Review (NDA206111, ORIG, p.16 |
| Efficacy and safety data duration | 52 | Boehringer Ingelheim — Synjardy FDA Review (NDA206111, ORIG, p.4 |
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.