) recently announced full data from the SAVOR study (n = 16,492)
on its diabetes drug, 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.
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The randomized, double-blind, placebo-controlled study evaluated
the use of 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
AstraZeneca has a collaboration agreement with Bristol-Myers
Squibb Company for the drug.
We note that 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% over the year-ago period.
We believe positive data from the study would have increased
Onglyza's share in the DPP-4 inhibitor market providing a much
needed boost to AstraZeneca's revenues. We note that key products
from AstraZeneca are facing generic competition
Key players in the diabetes market include
) among others.
AstraZeneca carries a Zacks Rank #3 (Hold). Companies that
currently look well-positioned include
), carrying a Zacks Rank #1 (Strong Buy).