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Novo Nordisk's Semaglutide in Tablet Form Gets FDA Approval

Novo Nordisk A/S NVO announced that the FDA has approved semaglutide in tablet form, which will be marketed under the brand name Rybelsus. It is approved as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. Rybelsus is expected to be launched in the fourth quarter of 2019.

Rybelsus is the first approved glucagon-like peptide-1 (GLP-1) receptor agonist in a tablet. The FDA approval was supported by results from 10 PIONEER studies, which included 9,543 adults with type II diabetes. Rybelsus more effectively lowered blood sugar than Januvia and Jardiance. Furthermore, treatment with the drug resulted in up to 4.4 kg reduction in body weight.

Rybelsus is also under review by several regulatory agencies, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

We remind investors that semaglutide is approved in the United States as a once-daily 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. It is marketed under the brand name Ozempic.

Shares of the company have gained 15.9% year to date compared with the industry’s growth of 0.5%.

We note that Novo Nordisk has a strong presence in the Diabetes care market, with a global value share of 28.3%. The company has one of the broadest diabetes portfolios in the industry. Solid performance from Tresiba, Victoza, Ozempic, Xultophy and Saxenda boosted sales in the second quarter of 2019.

The company is also foraying into areas other than diabetes. In July, Novo Nordisk and Gilead Sciences GILD 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 #3 (Hold).

Some better-ranked stocks in the large-cap pharmaceutical sector include Roche Holding AG RHHBY and Novartis NVS. Both companies carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Roche’s earnings per share estimates increased from $2.41 to $2.50 for 2019 and from $2.44 to $2.56 for 2020 over the past 90 days. Share price of the company has risen 14.9% year to date.    

Novartis’ earnings per share estimates increased from $5.06 to $5.15 for 2019 and from $5.71 to $5.77 for 2020 over the past 60 days. Share price of the company has gained 1.5% year to date.   

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