FDA Approves Semaglutide (OZEMPIC) for T2D Glycemic Control

The US Food and Drug Administration (FDA) has approved the new drug application (NDA) for semaglutide (OZEMPIC) injection once-weekly 0.5 mg or 1 mg as an adjunct glycemic control therapy in adults with type 2 diabetes (T2D).

OZEMPIC, a glucagon-like peptide (GLP-1) receptor agonist from Novo Nordisk, was approved based on results from a phase 3A clinical trial program. The 8 clinical trials consisted of more than 8,000 adults with T2D, and included a 2-year cardiovascular outcomes trial that tested the drug’s safety in adults with T2D at high risk of cardiovascular events.

It showed clinically meaningful and statistically significant reductions in blood glucose tests (A1c) versus placebo, sitagliptin and exenatide extended-release. In secondary endpoints, OZEMPIC reduced patient body weight.

The Novo Nordisk drug was compared to Trulicity (dulaglutide) in a randomized trial (SUSTAIN 7) in low (0.5 mg semaglutide versus 0.75 mg dulaglutide) and high (1.0 semaglutide versus 1.5 mg dulaglutide) doses.

OZEMPIC cut the hemoglobin A1C (HbA1C) of patients by 1.5% compared with 1.1% by dulaglutide at the low dose, and 1.8% compared with 1.4% at the high dose.

In the semaglutide low dose arm, 69% of patients met the ≤7.0% HbA1C target goal compared to 52% in the dulaglutide low dose arm. At the higher dose, 79% of patients met goal with semaglutide compared to 68% with dulaglutide.

The drug was backed with a 16-0 vote (with 1 abstention) in favor of approval by the FDA’s Endocrinologic and Metabolic Drugs advisory committee in October.

Eliot Brinton, MD, FAHA, FNLa, president of the Utah Lipid Center, told MD Magazine that the GLP-1 receptor agonist class is a “very interesting class for diabetes.”

Brinton noted the cardiovascular outcome benefits of semaglutide and liraglutide, which is not always a given in drugs that treat glycemia.

“A majority of recent trials have failed to show cardiovascular benefit. So, the fact we have data from these 2 trials with these 2 agents for cardiovascular disease reduction is very helpful,” Brinton said.

The drug class’ additional benefits in weight loss and glucose control have “created a lot of excitement in the field,” Brinton said. There’s motivation to prescribe the inhibitors with other agents, to treat cardiovascular events in patients with T2D.

“It's a very exciting time to be treating diabetes as we're now better empowered to address the question of how do we not only reduce glucose and keep that under control, but how do we also reduce cardiovascular disease, which is the number one cause of both death and disability in patients with type 2 diabetes,” Brinton said.

The therapy is indicated as an adjunct to diet and exercise, and is suitable for once-weekly dosing at any time of day. It is considered a longer-acting version of Victoza (liraglutide), a treatment approved for an additional indication of lowering cardiovascular risk in adult patients T2D in August.

OZEMPIC will be launched in the US in Q1 of 2018, according to Novo Nordisk. Semaglutide is currently review with the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

A press release regarding the approval was made available.

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