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Novo Nordisk's Ozempic Lowers Risk of Cardiovascular Events (revised)

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Novo Nordisk A/S (NVO - Free Report) announced post hoc results from the SUSTAIN 6 study in patients with type II diabetes and established cardiovascular disease (CV) or with at least one cardiovascular risk factor. The patients in the study were treated with Ozempic (semaglutide) compared to placebo, both in addition to standard of care.

The primary outcome measure of the study was a composite outcome of major adverse cardiovascular events (MACE), defined as non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. The study showed that patients treated with Ozempic had a significant 26% lower risk of MACE versus those receiving placebo for more than 2 years. Ozempic consistently reduced the risk of major cardiovascular events across type II diabetes population at high CV risk regardless of prior CV events at baseline.

The company also presented post-hoc pooled meta-analysis of the SUSTAIN 1-5 efficacy studies, which demonstrated a lower risk of MACE in people taking Ozempic. The comparators included in SUSTAIN 1-5 were placebo, Merck’s (MRK - Free Report) Januvia (sitagliptin), exenatide extended release and insulin glargine U100. Due to low number of events, this reduction did not achieve statistical significance.

We remind investors that in December 2017, the FDA approved Ozempic once-weekly pre-filled pen to improve glycaemic control in type II diabetes patients. It is also approved in Europe, Japan and Canada for the same indication.

Shares of the company have moved down 8.3% year to date compared with the industry’s growth of 5.6%.

Few days ago, the company also announced positive headline results from phase IIIa PIONEER 5 study of 14 mg oral formulation of Ozempic compared with placebo in adults with type II diabetes and moderate renal impairment controlled with metformin, sulfonylurea alone or in combination with metformin, or basal insulin alone or in combination with metformin.

The study met its primary endpoint according to the primary statistical approach by demonstrating a statistically significant and superior improvementin blood glucose levels (HbA1c), and statistically significant and superior weight loss at 26 weeks with oral Ozempic compared to placebo. 

During the second quarter of 2018, Novo Nordisk announced the phase IIIa results from four of the 10 clinical studies in the PIONEER program with oral semaglutide, for people with type II diabetes. The trials confirmed statistically significant reductions in both HbA1c and weight for oral semaglutide compared to Lilly’s (LLY - Free Report) Jardiance (empagliflozin), Januvia and Victoza.

Zacks Rank & Stock to Consider

Novo Nordisk carries a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Gilead Sciences Inc. (GILD - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Gilead’s earnings per share estimates have increased from $6.11 to $6.57 for 2018 and from $6.36 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%. The stock has rallied 2.7% so far this year.

(NOTE: We are reissuing this article to correct a mistake. The original article, issued August 27, 2018, should no longer be relied upon.)

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