US approves Ozempic, Novo Nordisk says EU and Japan up next
The US Food and Drug Administration (FDA) approved Novo Nordisk’s new drug application (NDA) for its once-weekly diabetes treatment Ozempic (semaglutide) following a positive recommendation from an FDA advisory committee in October.
Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist designed to improve glycaemic control in adults – alongside diet and exercise – in patients with type 2 diabetes.
The subcutaneous injection stimulates insulin and lowers glucagon secretion, and has high albumin binding properties, which the firm said results in a long half-life of approximately one week.
According to Novo Nordisk, in trials “Ozempic produced clinically meaningful and statistically significant reductions in HbA1c [haemoglobin A1c] compared with placebo, sitagliptin, exenatide extended release and insulin glargine U100.”
“Furthermore, in the trials, treatment with Ozempic resulted in statistically significant reductions in body weight.”
Novo Nordisk spokesperson Katrine Rud von Sperling told us the US is the first country to approve Ozempic.
“We expect approval in Europe and Japan in Q1 2018,” she said.
In the US the drug will be priced at parity to other GLP-1 products on the market, Rud von Sperling told us.