US label update for AstraZeneca/B-MS' Onglyza for renally-impaired diabetics

The US Food and Drug Administration has approved the inclusion of data from two clinical studies in an update to the Onglyza (saxagliptin) US Prescribing Information for adult type 2 diabetes patients. The drug is marketed by Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US partner Bristol-Myers Squibb (NYSE: BMY).

The renal study investigated the safety and efficacy of Onglyza in patients with moderate to severe renal impairment or end-stage renal disease (ESRD). The 12-week data showed that Onglyza 2.5mg once daily significantly improved glycosylated hemoglobin (HbA1c) from baseline compared to placebo when added to patients’ current diabetes treatment. In patients with ESRD, Onglyza and placebo showed numerically comparable reductions in HbA1c. This finding is inconclusive because the trial was not adequately powered to show efficacy within specific subgroups of renal impairment. The incidence of adverse events was similar between Onglyza and placebo.

The data from a separate 52-week study comparing Onglyza to titrated glipizide in patients with inadequate glycemic control on metformin therapy plus diet and exercise showed that Onglyza plus metformin provided similar HbA1c reductions from baseline. This conclusion may be limited to patients with baseline HbA1c comparable to those in the trial. Onglyza plus metformin also resulted in significantly less confirmed hypoglycemia, as well as weight loss compared to weight gain versus titrated glipizide plus metformin.