) 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
ASTRAZENECA PLC (AZN): Free Stock Analysis
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AstraZeneca has a collaboration agreement with Bristol-Myers
Squibb Company for the drug.
Key players in the diabetes market include
), among others.
AstraZeneca carries a Zacks Rank #3 (Hold). Companies that
currently look well-positioned include Novo Nordisk, carrying a
Zacks Rank #2 (Buy).