Komboglyze(saxagliptin)
Metabolic· 443 cited findings· 1 source document
Company: AstraZeneca PLC →
What the regulatory reviews say
Komboglyze (saxagliptin) is indicated for the treatment of type 2 diabetes mellitus. Efficacy findings include a plasma DPP-4 activity inhibition (trough) of 80% with saxagliptin 2.5 mg BID. When combined with metformin, saxagliptin 2.5 mg resulted in an HbA1c decrease of -0.73% versus placebo (95% CI: -0.92, -0.53%), while saxagliptin 5 mg resulted in an HbA1c decrease of -0.83% versus placebo (95% CI: -1.02, -0.63%). Saxagliptin 2.5 mg monotherapy showed an HbA1c change from baseline of -0.69% compared to placebo (95% CI: -1.02, -0.35%).
Safety data indicate increased exposure to BMS-510849 (a saxagliptin metabolite) in patients with renal impairment: 1.7-fold higher in mild, 2.9-fold higher in moderate, and 4.5-fold higher in severe renal impairment. Saxagliptin exposure was 60% higher in elderly patients (>=65 years) compared to young patients (18-40 years). The maximum daily dose of saxagliptin is 5 mg, and metformin hydrochloride is 2 gram.
The Marketing Authorisation application was submitted on 21 July 2010, and a CHMP positive opinion was issued on 22 September 2011. Proposed dose strengths are 2.5 mg/850 mg and 2.5 mg/1000 mg.
Key figures — cited to the source page
| Plasma DPP-4 activity inhibition (trough) with saxagliptin 2.5 mg BID | 80 | AstraZeneca PLC — Komboglyze EMA EPAR public assessment repo, p.27 |
| HbA1c decrease vs placebo for saxagliptin 2.5 mg + metformin | -0.73 | AstraZeneca PLC — Komboglyze EMA EPAR public assessment repo, p.29 |
| 95% CI for HbA1c decrease vs placebo for saxagliptin 2.5 mg + metformin | -0.92, -0.53 | AstraZeneca PLC — Komboglyze EMA EPAR public assessment repo, p.29 |
| HbA1c decrease vs placebo for saxagliptin 5 mg + metformin | -0.83 | AstraZeneca PLC — Komboglyze EMA EPAR public assessment repo, p.29 |
| 95% CI for HbA1c decrease vs placebo for saxagliptin 5 mg + metformin | -1.02, -0.63 | AstraZeneca PLC — Komboglyze EMA EPAR public assessment repo, p.29 |
| BMS-510849 exposure in severe renal impairment (19-30 ml/min) | 4.5 | AstraZeneca PLC — Komboglyze EMA EPAR public assessment repo, p.22 |
| Saxagliptin AUC in elderly patients (>=65 years) vs young patients (18-40 years) | 60 | AstraZeneca PLC — Komboglyze EMA EPAR public assessment repo, p.23 |
| Marketing Authorisation application submission date | 21 July 2010 | AstraZeneca PLC — Komboglyze EMA EPAR public assessment repo, 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.