FDA Approves Ozempic, A Powerful Once-Weekly Type 2 Diabetes Medication

The U.S. Food and Drug Administration (FDA) has approved the once-weekly injectable Ozempic (semaglutide) for use in type 2 diabetes.

Ozempic, a GLP-1 agonist, demonstrated significant A1c reductions (nearly 2%!) as well as weight loss in clinical trials. Though the approval was anticipated following a unanimous vote in favor of approval by an FDA advisory committee in October, it happened faster than expected. Ozempic will be available in the US within the first three months of 2018.

The one concern that came up during the FDA approval process was a slightly higher rate of retinopathy (eye damage) observed in Ozempic users in one clinical trial – 3% of Ozempic users experienced retinopathy compared to 1.8% of those taking placebo.

The FDA addressed this by including a warning on Ozempic’s label about this risk, especially when first starting the drug. The slightly higher retinopathy risk may be linked to very rapid reductions in A1c when starting the medication. Many insulins feature a similar warning. This warning is especially relevant for people who already have some history of retinopathy prior to starting Ozempic.

Ozempic is now the fourth once-weekly injectable GLP-1 agonist to be approved in the US, joining Trulicity (dulaglutide), Bydureon (exenatide), and soon-to-be discontinued Tanzeum (albiglutide).

In a recently reported “head-to-head” trial, Ozempic showed greater A1c reduction than Trulicity (1.8% versus 1.4%) as well as greater weight loss (10-14 pounds versus 5-7 pounds). Ozempic had similarly shown greater A1c and weight reductions than Bydureon in an earlier trial. There are also once-daily GLP-1 agonists, Victoza (liraglutide) and Adlyxin (lixisenatide).

Novo Nordisk has indicated that Ozempic will be priced “on par” with other once-weekly GLP-1 agonists, meaning those with insurance coverage should pay a similar amount to other drugs in this class.

We’d guess copay savings cards will be available for those without insurance coverage, similar to Victoza’s Instant Savings Card. Ozempic will come in a prefilled, disposable FlexTouch pen.

Following this FDA approval, Novo Nordisk is also working towards two more possible developments for this drug

• A study to assess whether Ozempic has benefits for heart health

• A study in 2018 on the use of Ozempic specifically as a weight-loss therapy for obesity.

A pill version of Ozempic is also in clinical trials; this could very likely be the first GLP-1 agonist not to require any injections at all.