By Sriparna Roy and Mariam Sunny
LONDON: Advisers to the US health regulator voted against its use on Friday. Novo Nordisk’s Weekly Insulin Risk factors in patients with type 1 diabetes low blood sugar,
The Food and Drug Administration’s panel of independent experts voted by a 7-4 majority to recommend that the weekly Insulin Icodecthe benefits do not outweigh the risks
Novo aims to be the first company to market with a weekly insulin product, offering an option for patients with types 1 and 3. Type 2 diabetes Who are now dependent on multiple injections daily.
“I am concerned that approving the use of (insulin) Icodec at this time with insufficient data may be a disincentive for further trials, which I believe are needed to use it safely in type 1 diabetics,” said panel chair Cecilia Lo Wang.
The comments come after FDA staff on Wednesday flagged a risk of low blood sugar in the U.S. Type 1 diabetes patientsthose who are more insulin dependent, and have a deficiency of insulin clinical data Supporting Novo’s proposed methods to mitigate the risks associated with HypoglycemiaA condition in which the blood sugar level drops below the standard range.
Novo said it will continue to work closely with the FDA to identify the next steps needed to bring this treatment to market.
Speaking ahead of the panel meeting, Hargreaves Lansdown analyst Darren Nathan said the rise in hypoglycemic events in type 1 diabetics could prove a barrier for these patients.
Barclays analyst Emily Field said the FDA’s decision not to recommend approval for type 1 patients is reasonable, but Novo could still seek approval for type 2 patients, which is a larger market.
Although the FDA generally follows the recommendations of its expert panels, it is not obligated to do so.
Earlier this week, the weekly basal injection under the brand name ‘Avicli’ was approved for use in the European Union, the Danish drugmaker said on Friday.
Basal insulin helps control blood sugar levels throughout the day, while bolus insulin controls the rise in blood sugar levels after meals.
Rival Eli Lilly is also developing its own weekly insulin injection, Effetora.
(Reporting by Sreeparna Roy and Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)
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