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Novo Nordisk's Ozempic Gets FDA Nod for CV Risk Reduction

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Novo Nordisk A/S (NVO - Free Report) 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 industry’s growth of 14.2%.

The company also said that the label of Rybelsus (semaglutide in tablet form) is being updated to include data from the PIONEER 6 CVOT study demonstrating CV safety. The drug demonstrated CV safety by meeting the primary endpoint of non-inferiority for the composite MACE endpoint The proportion of patients who experienced at least one MACE was 3.8% with Rybelsus and 4.8% with placebo.

We note that  Novo Nordisk has a strong presence in the Diabetes care market, with a global value share of 28.4%. The company has one of the broadest diabetes portfolios in the industry.. In July, Novo Nordisk and Gilead Sciences (GILD - Free Report) initiated a phase II proof-of-concept study combining the former’s semaglutide and the latter’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the treatment of patients with nonalcoholic steatohepatitis (NASH).


Zacks Rank and Stocks to Consider

Novo Nordisk currently has a Zacks Rank #4 (Sell).

A few better-ranked stocks from the healthcare space are Pfizer, Inc. (PFE - Free Report) and Eli Lilly & Co. (LLY - Free Report) . While Pfizer sports a Zacks Rank #1 (Strong Buy), Lilly carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Pfizer’s earnings per share estimates have moved up from $2.93 to $2.96 for 2019 and from $2.58 to $2.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise of 8.73%, on average, in the last four quarters.

Lilly’s earnings per share estimates have increased from $5.79 to $5.80 for 2019 and from $6.56 to $6.77 for 2020 in the past 60 days. The company posted a positive earnings surprise in one of the last four quarters, with an average beat of 1.20%.

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