USFDA panel votes against Novo Nordisk weekly insulin use in type 1 diabetes patients
Advisers to the U.S. health regulator cast their votes opposing the utilization of Novo Nordisk's weekly insulin for patients with type 1 diabetes, citing concerns about the potential for low blood sugar levels. The panel of independent experts from the Food and Drug Administration voted 7 to 4, asserting that the benefits of the weekly insulin icodec are not justified by the associated 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, according to Reuters.
"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 is also developing its own once-weekly insulin injection, efsitora.
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