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US FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
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US FDA panel votes against Novo Nordisk's weekly insulin in type 1 diabetes patients
May 24, 2024 2:57 PM

May 24 (Reuters) - Advisers to the U.S. health regulator

on Friday voted against the use of Novo Nordisk's

weekly insulin in patients with type 1 diabetes due to risks of

low blood sugar.

The Food and Drug Administration's panel of independent

experts voted 7-to-4, saying the weekly insulin icodec's

benefits do not outweigh the risks

Novo is aiming to be the first to hit the market with a

weekly insulin product, offering an alternative for patients

with type 1 and type 2 diabetes who now depend on multiple daily

injections.

"I'm concerned that approving (insulin) icodec for use at

this point with inadequate data might be a disincentive for

further trials, which I think are needed in order to use it

safely in type one diabetics," said Cecilia Low Wang, the panel

chairperson.

The comments come after the FDA's staff on Wednesday flagged

the risk of low blood sugar in type 1 diabetes patients, who are

more insulin-dependent, and the lack of clinical data to support

Novo's proposed methods for mitigating the risks associated with

hypoglycemia, a condition in which blood sugar levels drop below

the standard range.

Novo said it will continue to work closely with the FDA to

identify the next steps needed to bring the treatment to market.

The increase of hypoglycemic events for type 1

diabetics, could prove a barrier for these patients, Derren

Nathan, analyst at Hargreaves Lansdown said ahead of the panel

meeting.

Barclays analyst Emily Field said it was plausible for

the FDA to not recommend approval in type 1 patients, but that

Novo could still seek approval for type 2 patients, which is a

larger market.

While the FDA usually follows the recommendations of its

expert panel, it is not obligated to do so.

The weekly basal injection, under the brand name Awiqli, was

approved earlier this week for use in the European Union, the

Danish drugmaker said on Friday.

Basal insulin helps regulate blood glucose levels throughout

the day compared to bolus insulin which manages blood glucose

rise after meals.

Rival Eli Lilly ( LLY ) is also developing its own

once-weekly insulin injection, efsitora.

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