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.
The Food and Drug Administration’s panel of independent experts voted 7 to 4, saying the benefits of the weekly insulin codec do not outweigh the risks.
Novo aims to be first to market with weekly insulin, offering an alternative to patients with type 1 and type 2 diabetes who now rely on multiple daily injections.
“I’m concerned that approving the (insulin) codec for use at this stage with insufficient data may be a deterrent to further research, which I think is necessary for its safe use in type 1 diabetes,” said Cecilia Low Wang, chairman collegium.
The comments came after FDA staff on Wednesday noted the risk of low blood sugar in patients with type 1 diabetes, who are more insulin-dependent, and the lack of clinical data to support Novo’s proposed methods for reducing the risks associated with the hypoglycemia condition. in which blood sugar levels fall below the standard range.
Novo said it will continue to work closely with the FDA to determine the next steps needed to bring the drug to market.
The rise in hypoglycaemia in type 1 diabetics could be a barrier for these patients, Derren Nathan, an analyst at Hargreaves Lansdown, said ahead of the panel meeting.
Barclays analyst Emily Field noted that it’s likely the FDA won’t recommend approval of the drug for Type 1 patients, but Novo could still seek approval for Type 2 patients, which is a larger market.
Although the FDA generally follows its review panel’s recommendations, it is not required to do so.
A weekly basal injection, branded 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 levels after meals.
Rival Eli Lilly (NYSE:) is also developing its own once-weekly “efcitor” insulin injection.