Novo Nordisk's Ozempic Gets FDA Nod For CV Risk Reduction
Zacks Investment Research | Jan 17, 2020 07:47AM ET
Novo Nordisk (CSE:NOVOb) A/S (NYSE:NVO) announced that the FDA has approved a label expansion of its once-weekly injection Ozempic to lower the risk of cardiovascular events. The FDA approved the supplemental new drug application (sNDA) for Ozempic for reducing the risk of major adverse cardiovascular (CV) events (MACE) including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type II diabetes and established cardiovascular disease (CVD).
The approval was based on data from the SUSTAIN 6 cardiovascular outcomes trial (CVOT). The study showed that Ozempic statistically significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 26% versus placebo, when added to standard of care in the above mentioned patient population.
We remind investors that Ozempic is approved in the United States as a once-daily pre-filled pen to improve glycemic control in type II diabetes patients. It is also approved in Europe, Japan and Canada for the same indication.
Shares of the company have gained 27.6% in the past year compared with the Zacks Investment Research
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