Sydbank: Lack of recommendation for Novo Nordisk's new insulin "not the end of the world"

Sydbank analyst Søren Løntoft Hansen points out that Friday’s ’no’ from an FDA expert panel does not mean game over in terms of approval at a later date.
Photo: Tom Little/Reuters/Ritzau Scanpix
Photo: Tom Little/Reuters/Ritzau Scanpix
by marketwire

A US Food and Drug Administration (FDA) expert panel voted no on Friday evening to the question of whether Awiqli’s benefits outweigh the risks in relation to blood sugar control in adult type 1 diabetics - but investors shouldn’t be concerned, says Søren Løntoft Hansen, Senior Analyst at Sydbank.

Firstly, the sales potential is far greater in type 2 diabetes, for which Awiqli - according to Hansen - is far better suited, and secondly, it was a divided panel that wanted to see more data.

”It’s not the end of the world. There was disagreement in the expert panel. Several of those who voted ’no’ think it’s an exciting product, but would like to see a little more data and something more in relation to these cases of low blood sugar,” says Hansen to Marketwire.

The panel recommends whether drugs should be approved or not, which the FDA takes into consideration when making its final decision. 

Four panel members voted ”yes” and seven voted ”no”. Part of the concern was the potential risk of hypoglycemia - a sudden, large drop in blood sugar levels.

The fact that Awiqli was initially rejected by the panel doesn’t mean that it’s a done deal in terms of approval at a later date.

”We would like to see a little more data, and perhaps what data from the ”real world” looks like when this drug is probably approved for the treatment of type 2 diabetes. So it’s not like it can’t be approved later when we’ve learned more,” says Hansen. 

English edit: Catherine Brett

Share article

Sign up for our newsletter

Stay ahead of development by receiving our newsletter on the latest sector knowledge.

Newsletter terms

Front page now

Further reading