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Novo Nordisk's Ozempic Gets Canadian Approval for Diabetes

Novo NordiskNVO announced that Health Canada has approved Ozempic (semaglutide injection) to improve glycemic control in adults with type II diabetes mellitus, when metformin is not tolerated or contraindicated. Ozempic, a once-weekly glucagon-like peptide 1 (GLP-1) receptor agonist, can also be used together with other antidiabetic drugs when diet and exercise do not achieve adequate glycemic control.

Shares of the company have rallied 52.4% compared with the industry 's gain of 16.8% in the past year.

The approval of Ozempic was based on results from the phase III SUSTAIN study. The results showed that people with type II diabetes, who are treated with once-weekly semaglutide, experienced statistically significant and sustained blood glucose control compared with Merck's Januvia (sitagliptin), Astrazeneca's once-weekly Bydureon (exenatide extended-release), Sanofi's Lantus (insulin glargine) and placebo.

The approval of Ozempic was based on results from the phase III SUSTAIN study. The results showed that people with type II diabetes, who are treated with once-weekly semaglutide, experienced statistically significant and sustained blood glucose control compared with Merck's MRK Januvia (sitagliptin), Astrazeneca's AZN once-weekly Bydureon (exenatide extended-release), Sanofi's SNY Lantus (insulin glargine) and placebo.

In December 2017, the FDA approved Ozempic once-daily pre-filled pen to improve glycaemic control in type II diabetes patients. European regulatory authorities also adopted a positive opinion, recommending marketing authorization for Ozempicon Dec 15.

Additionally, Novo Nordisk is making efforts to develop new treatments for diabetes, which is its core area of expertise. In September 2017, the company received approval for its fast acting insulin aspart, Fiasp. Other than semaglutide, its key pipeline candidate includes nonacog beta pegol.

The approval of the drug will give a boost to the company's revenues.

Novo Nordisk A/S Price

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Zacks Rank

Novo Nordisk carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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