United States: Due to the possibility of low blood sugar, advisers to the US health regulator on Friday voted against the weekly administration of Novo Nordisk insulin to patients with type 1 diabetes.
Risks Outweigh Benefits
The benefits of the weekly insulin injection do not outweigh the risks, according to a panel of independent experts from the Food and Drug Administration that voted 7–4. Novo is hoping to be the first company to introduce a weekly insulin product to the market, providing patients with type 1 and type 2 diabetes who currently require multiple daily injections with an alternative.
Call for Further Trials
“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 chair of the panel.
FDA’s Cautionary Warning
The remarks follow the FDA staff’s warning on Wednesday about the possibility of low blood sugar in patients with type 1 diabetes, who are more insulin-dependent, as well as the lack of clinical evidence to back up Novo’s suggested strategies for reducing the risks of hypoglycemia, a condition in which blood sugar levels fall below the normal range.
Collaboration with FDA Continues
According to Novo, it will keep collaborating closely with the FDA to determine what has to happen next in order to get the medicine on the market.
Before the panel discussion, Derren Nathan, an analyst at Hargreaves Lansdown, stated that the rise in hypoglycemia episodes among type 1 diabetics may be a challenge for these patients.
Potential Market Strategy
The FDA might decide not to recommend approval for type 1 patients, according to Barclays analyst Emily Field, but Novo could still pursue clearance for type 2 patients, which represents a larger market.
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FDA Decision and Market Authorization
The FDA is not required to abide by the advice of its expert panel, even though it typically does. According to the Danish drugmaker on Friday, the weekly basal injection, marketed under the brand name Awiqli, was authorized for use in the European Union earlier this week.
As opposed to bolus insulin, which controls the rise in blood sugar levels following meals, basal insulin aids in controlling blood sugar levels throughout the day.