By Sriparna Roy and Mariam Sunny
London: 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 is also developing its own once-weekly insulin injection, efsitora.
(Reporting by Sriparna Roy and Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)
