Novo Nordisk wins FDA approval for higher-dose Ozempic for adults with type 2 diabetes

FDA has approved a 2 mg injectable dose of Novo Nordisk’s (NYSE:NVO) Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog. The indication covers improving blood sugar control and reducing the risk of cardiovascular complications in adults with type 2 diabetes when used in conjunction with diet and exercise changes.

To win the new indication, the Bagsværd, Denmark–based company provided data showing the 2 mg dose led to an average 2.1% blood glucose reduction and weight loss in adults with type 2 diabetes.

In the SUSTAIN Phase 3 clinical trial, a 1 mg dose of Ozempic helped up to 73% of people with type 2 diabetes reach the American Diabetes Association target of <7%.

Ozempic image courtesy of Novo Nordisk

The 2 mg dose could help individuals who need additional glycemic control.

“With its proven safety and efficacy, Ozempic helps deliver on blood glucose control…

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Novo Nordisk to test oral semaglutide as an obesity therapy

Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity. 

The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’ risk of major adverse cardiovascular events. 

The most recent Phase 3a trial will test an oral 50-mg dose of the drug with roughly 1,000 volunteers who are obese or overweight with comorbidities. 

The company anticipates that the 68-week study will kick off in the second half of 2021. 

Recent clinical trial results indicate that subcutaneous semaglutide paired with behavioral therapy can support weight loss. 

Novo Nordisk has also filed a new drug application with the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The company is seeking a similar indication in the European m…

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Semaglutide shows promise for weight loss maintenance 

Signs are growing that the diabetes drug Ozempic (semaglutide) from Novo Nordisk can support weight loss in overweight and obese individuals.

A recent JAMA study involving overweight and obese individuals gave recipients a 2.4-mg subcutaneous dose of semaglutide once weekly for 20 weeks. After that period, investigators continued administering the drug to half of the participants while giving the placebo to the remainder for an additional 48 weeks.

The group that continued to receive semaglutide lost an average of 7.9% of their body weight from week 20 to week 68. By contrast, placebo recipients gained 6.9% of their body weight in the same time frame.

Complicating matters were gastrointestinal side effects, reported in 49.1% of participants who continued to receive subcutaneous semaglutide. A total of 26.1% of placebo recipients also reported gastrointestinal side effects.

The study authors conclude that semaglutide supports weight loss by improvi…

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FDA sends Novo Nordisk refusal to file letter for weekly 2-mg semaglutide 

Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide).

The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021.

The letter indicates that FDA has concluded additional information is needed to review an application.

FDA requested information related to the new proposed manufacturing site for the drug.

Novo Nordisk stated that it believes it has sufficient data to warrant the label expansion application.

The company plans to resubmit the application to FDA in the second quarter of 2021.

The current FDA labeling recommends patients begin taking 0.25 mg of semaglutide once weekly, increasing to 0.5 mg after four weeks. Patients who require additional glycemic control can have the dose to 1 mg once weekly after an additional four weeks…

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Semaglutide paired with behavioral therapy tripled weight loss in trial

The diabetes drug Ozempic (semaglutide) could potentially enhance weight loss in overweight and obese patients without diabetes, according to a study recently published in JAMA and The New England Journal of Medicine.

In December, Novo Nordisk (NYSE:NVO) submitted a new drug application to the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management.

The drug won FDA approval to manage type 2 diabetes in 2017

The 68-week randomized Phase 3a study involved 611 patients. At the end of the period, patients given weekly semaglutide lost 16% of their body weight while the placebo group lost 5.7%.

Participants in the trial received physical activity counseling. At the beginning of the trial, they received an eight-week meal replacement diet of 1000 to 1200 calories per day.

Some 3.4% of semaglutide recipients had gastrointestinal adverse events, and treatment for them was discontinued.

The study was conducted from Au…

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