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January 17, 2020

Novo Nordisk secures FDA expanded indication for Ozempic

The US Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s Ozempic (semaglutide).

The US Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s Ozempic (semaglutide).

The once-weekly injection is now indicated to reduce the risk of major adverse cardiovascular events (MACE), such as non-fatal heart attack or stroke and cardiovascular death, in adults with type 2 diabetes and established cardiovascular disease (CVD).

FDA approved the label expansion based on the results of SUSTAIN 6 cardiovascular outcomes trial (CVOT).

The trial found that Ozempic significantly reduced the risk of CV death as well as non-fatal heart attack or stroke by 26% compared to placebo when added to standard of care in 3,297 adult subjects with type 2 diabetes and high CV risk.

Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said: “We strongly believe in the benefits of semaglutide and this approval marks an important milestone.

“Ozempic now offers people in the US with type 2 diabetes and established cardiovascular disease an effective treatment option to both lower their blood glucose and reduce their cardiovascular risk.”

Ozempic is an analogue of the naturally occurring hormone glucagon-like peptide-1 (GLP-1), administered in a once-weekly injection of 0.5mg or 1mg, indicated to improve glycaemic control in adults with type 2 diabetes.

It was first approved by FDA in 2017 and is now available in 25 countries.

Simultaneously, the FDA also updated the label of Rybelsus (oral semaglutide), indicated for improving glycaemic control in adults with type 2 diabetes.

Rybelsus label now includes additional information from the PIONEER 6 CVOT that demonstrated CV safety of the medication.

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