Update on AstraZeneca's Onglyza

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AstraZeneca’s (AZN) diabetes drug, Onglyza is approved as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults suffering from type II diabetes. Onglyza revenues as recorded by AstraZeneca were $102 million in the second quarter of 2013, reflecting an increase of 28% year over year.

In early September, the company had announced data from the SAVOR study (n = 16,492) on Onglyza, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Onglyza failed to meet the primary efficacy endpoint of the study.

Onglyza did not prove to be superior to placebo with respect to a composite endpoint including cardiovascular death, non-fatal myocardial infarction (:MI) or non-fatal ischemic stroke. However, the drug met the primary safety objective of non inferiority to placebo for the same composite endpoint.

The randomized, double-blind, placebo-controlled study evaluated Onglyza as a combination therapy in patients suffering from type II diabetes, with a history of established cardiovascular disease or multiple risk factors. Some of these patients also suffered from renal impairment. It was found in the study that the primary composite endpoint of cardiovascular death, non-fatal MI or non-fatal ischemic stroke occurred in 7.3% of the patients in the Onglyza arm as compared to 7.2% in the placebo arm.

However, new data from the SAVOR cardiovascular outcomes trial released later in September revealed no difference in the rate of hypoglycemia among patients treated with Onglyza, compared to placebo when added to metformin monotherapy. A Higher rate of hypoglycemia in the Onglyza arm compared to placebo was only found among patients taking sulfonylureas.

Data also revealed that a greater number of patients treated with Onglyza achieved the target HbA1c level without hypoglycaemia versus those in the placebo arm. However this was not the case in patients who had received only sulfonylureas at baseline.

AstraZeneca has a collaboration agreement with Bristol-Myers Squibb Company for the drug.

Key players in the diabetes market include Novo Nordisk (NVO), Merck (MRK) and Sanofi (SNY), among others.

AstraZeneca carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Novo Nordisk, carrying a Zacks Rank #2 (Buy).

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