By Sriparna Roy and Mariam Sunny
(Reuters) – Advisers to the U.S. health regulator voted on Friday against the use of Novo Nordisk's (NYSE ) weekly insulin in patients with type 1 diabetes due to the risk of low blood sugar levels.
The Food and Drug Administration's independent expert panel voted 7 to 4, saying the benefits of weekly insulin icodec do not outweigh the risks.
Novo aims to be first to market with a weekly insulin product, offering an alternative for patients with type 1 and type 2 diabetes who now rely on multiple daily injections.
“I am concerned that approving (insulin) icodec for use at this time with inadequate data may be a disincentive to conduct further trials, which I believe are necessary to be able to use it safely in type one diabetics,” Cecilia Low Wang said. , the president of the panel.
The comments come after FDA staff on Wednesday noted the risk of low blood sugar in patients with type 1 diabetes, who are more dependent on insulin, and the lack of clinical data supporting the methods. proposed by Novo to mitigate the risks associated with hypoglycemia, a condition in which blood sugar levels fall 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.
Increased episodes of hypoglycemia in type 1 diabetics could pose a barrier for these patients, Derren Nathan, an analyst at Hargreaves Lansdown, said before the panel meeting.
Barclays analyst Emily Field said it was plausible that the FDA would 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 typically follows the recommendations of its expert panel, it is not required 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 controls the rise in blood glucose after meals.
Rival Eli Lilly is also developing its own weekly insulin injection, efsitora.
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