Novo Nordisk NVO announced that it submitted a New Drug Application (NDA) for faster-acting insulin aspart to the FDA.
This mealtime insulin is being developed for improved control of postprandial glucose excursions and for the treatment of people with type I and type II diabetes.
Novo Nordisk filed for the candidate based on positive results from the clinical onset trial, wherein approximately 2100 patients with type I and II diabetes were treated. Results from the trial showed that patients treated with faster-acting insulin aspart achieved improvement in postprandial glucose control compared to NovoLog and an HbA1c reduction on par with NovoLog.
Moreover, patients with type I diabetes showed significantly higher HbA1c reduction when dosed at mealtime or similar HbA1c reduction when dosed 20 minutes after a meal with faster-acting insulin aspart as compared to NovoLog.
We remind investors that last week, the company also submitted a regulatory filing for faster-acting insulin aspart with the European Medicines Agency.
Novo Nordisk plans to deliver faster-acting insulin aspart in the prefilled delivery device, FlexTouch. A potential approval in both the U.S. and the EU will further strengthen Novo Nordisk’s diabetes portfolio. We note that the company has a strong presence in the Diabetes Care market and boasts a strong pipeline, with focus on therapeutic proteins within insulin. Victoza remains the growth engine at the company.
Novo Nordisk carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Eli Lilly and Company LLY, Pfizer, Inc. PFE and Bristol-Myers Squibb Company BMY. All three carry a Zacks Rank #2 (Buy).
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