Ozempic (semaglutide) Injection Pen

Semaglutide Approved for Type 2 Diabetes

Late yesterday, a new, once-weekly injection for type 2 diabetes cleared the hurdle of FDA approval for sale. Semaglutide, will be available early next year in a familiar pen injection device. It will come in two doses: 0.5 and 1.0 mg once weekly. For people with type 2 diabetes it’s great to have a once-weekly option. And for folks with both diabetes and obesity, the added bonus is a bit of weight loss – roughly 5% in clinical trials.

Novo Nordisk says it will sell semaglutide at a price comparable to other drugs in its class, known as GLP-1 agonists. One of those other drugs is liraglutide. Novo Nordisk sells it as Victoza for diabetes and as Saxenda at a higher dose for obesity. Lilly sells a weekly GLP-1, dulaglutide, under the brand name of Trulicity. Trulicity is only indicated for diabetes.

A Work in Progress for Better Obesity Care

Semaglutide Phase 2 Obesity ResultsBut for us, the real importance of this news is a step toward better obesity care. At this low dose for diabetes, the effect on obesity is modest, a bit less than what would be required for an anti-obesity medication to gain approval. However, at higher doses for obesity, Novo Nordisk reports weight loss of as much as 16%.

If this efficacy holds up in pivotal phase 3 studies, semaglutide will offer a big step forward in effectiveness for obesity treatment.

Those studies will start in 2018 and continue into 2020. The dose will be considerably higher than the dose for diabetes – 2.4 mg once a week. One of those studies will be a massive study of cardiovascular outcomes in 12,500 people with obesity (and not diabetes).

This drug has much promise for better obesity care. Time will tell if the promise is real.

Click here, here, and here for more on the semaglutide approval. For the Ozempic package insert, click here.

Ozempic (semaglutide) Injection Pen, photograph © Novo Nordisk

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December 6, 2017

One Response to “Semaglutide Approved for Type 2 Diabetes”

  1. December 06, 2017 at 9:57 am, Allen Browne said:

    Progress – now we need the oral form.

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