New GLP-1; Semaglutide (Ozempic)

The US Food and Drug Administration (FDA) has approved semaglutide (Ozempic, Novo Nordisk) as an adjunct to diet and exercise for the treatment of type 2 diabetes in adults.

This once weekly injection of (GLP-1) receptor agonist will be available in 0.5-mg and 1.0-mg doses, via a dedicated prefilled pen device.

Semaglutide is the seventh GLP-1 receptor agonist on the US market and the third dosed once weekly. And the data suggests it might be more effective than some of its competitors.

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The company’s eight phase 3a trials involved over 8000 adults with type 2 diabetes, including individuals at high cardiovascular risk and those with renal disease. One of the studies, SUSTAIN-6, was a 2-year FDA-mandated cardiovascular-outcomes trial involving 3297 patients.

• In the five SUSTAIN efficacy trials, semaglutide reduced hemoglobin A1c by 1.5 to 1.8 percentage points.
• Semaglutide was also associated with a 4.5- to 6.4-kg weight loss. The most common side effect was mild to moderate nausea, which diminished over time.

After approval, Novo Nordisk is required to conduct a pediatric trial in adolescents younger than 18 years of age and to add semaglutide to a 15-year medullary thyroid carcinoma registry that includes all of the long-acting GLP-1 products.

Semaglutide will be priced similarly to current weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce copays for eligible commercially insured patients.