By Mariam Sunny and Sriparna Roy

London: The U.S. Food and Drug Administrationon Wednesday, the staff of Novo Nordisklong acting weekly insulin there was an increased risk of low blood sugar In patients type 1 diabetesThose who are more insulin dependent.

Novo aims to be the first to bring a weekly insulin product to market, offering an alternative to daily insulin injections for the millions of patients with type 1 diabetes and the more common type 2 patients.

The company has proposed a label to suggest continued use. glucose monitoring device FDA reviewers said it is an effective way, in addition to other methods, to measure blood sugar in patients with type 1 diabetes.

However, FDA staff said that was not the case. 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 has tested its weekly insulin Icodec in six late-stage trials involving more than 4,000 adults with diabetes, only one of which tested it in patients with type 1 diabetes.

In the trial, patients with type 1 diabetes taking insulin Icodec had 50 percent to 80 percent more clinically significant or severe hypoglycemia than the once-daily insulin degludec, which Novo sells under the brand name Tresiba. .

Richard Siegel, associate professor at Tufts University School of Medicine, told Reuters ahead of the review documents that patients with type 1 diabetes are certainly at higher risk of hypoglycemia.

“There should probably be a discussion about how much change should be made from week to week if blood sugar levels are not on target,” Siegel said.

A panel of independent FDA advisers will meet Friday to vote on whether insulin Icodec’s benefits outweigh its risks.

F.D.A. The advisor is not obliged to follow the panel’s recommendations, but he or she usually does.

Rival Eli Lilly is also developing its own weekly insulin injection, Efficora, shown here decrease in blood sugar Corresponding to commonly used daily insulin in two studies in patients with type 2 diabetes.

(Reporting by Mariam Sunny and Sriparna Roy in Bengaluru; Editing by Taseem Zahid and Shilpi Majumdar)