Novo Nordisk Receives FDA Approval for Awiqli Injection
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy NVO?
The company states: "Novo Nordisk announced that the FDA has approved Awiqli injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control in adults living with type 2 diabetes. The approval offers the only once-weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes. The approval is based on results from the ONWARDS phase 3a programme in type-2-diabetes for once-weekly Awiqli(R) injection, which comprises four randomised, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists. The clinical programme evaluated once-weekly Awiqli(R) vs daily basal insulin and demonstrated efficacy in the primary endpoint of HbA1c reduction across the ONWARDS pivotal clinical trial programme in adults with type 2 diabetes. Across ONWARDS trials, the safety profile of Awiqli(R) was overall consistent with the daily basal insulin class."
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Analyst Views on NVO
Wall Street analysts forecast NVO stock price to rise
8 Analyst Rating
4 Buy
3 Hold
1 Sell
Moderate Buy
Current: 36.040
Low
42.00
Averages
54.67
High
70.00
Current: 36.040
Low
42.00
Averages
54.67
High
70.00
About NVO
Novo Nordisk A/S is a global healthcare company engaged in diabetes care. The Company is also engaged in the discovery, development, manufacturing and marketing of pharmaceutical products. The Company operates through two business segments: diabetes and obesity care, and biopharmaceuticals. The Company's diabetes and obesity care segment covers insulin, GLP-1, other protein-related products, such as glucagon, protein-related delivery systems and needles, and oral anti-diabetic drugs. The Company's biopharmaceuticals segment covers the therapy areas of hemophilia care, growth hormone therapy and hormone replacement therapy. The Company also offers Saxenda product to treat obesity. It offers a range of products, including NovoLog/NovoRapid; NovoLog Mix/NovoMix; Prandin/NovoNorm; NovoSeven; Norditropin, and Vagifem. As of December 31, 2016, it marketed its products in over 180 countries. Its regional structure consists of two commercial units: North America and International Operations.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Rising Food Prices: Schneider notes that the increase in food and fertilizer prices is closely tied to energy prices, particularly as the DBA index shows a significant breakout in soft and agricultural commodities, suggesting potential inflationary pressures in the market.
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