Drugs

Hypoglycemia Risk in Novo’s Weekly Insulin: FDA

FDA medical reviewers say there was an increased risk of hypoglycemia in patients with Type 1 diabetes taking Novo Nordisk’s Awiqli (insulin icodec) once-weekly insulin. The reviewers’ comments are in a briefing document released in advance of a 5/24 meeting of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss Novo’s BLA.

The company hopes to be the first to offer a weekly insulin product as an alternative to daily insulin injections for patients with Type 1 and 2 diabetes.

While the company has proposed a label suggesting using continuous glucose monitoring devices for monitoring blood sugar in Type 1 diabetes patients, the reviewers say there is no clinical data to support Novo’s proposed methods for mitigating the risks associated with hypoglycemia.

The briefing document says data from the ONWARDS 6 trial showed higher incidence of level 2 (clinically significant) and level 3 (severe) hypoglycemia in those on insulin icodec compared to the active comparator, Novo Nordisk’s Tresida (insulin degludec) in patients with Type 1 diabetes.

FDA is asking the advisors to discuss:

the benefits and risks of insulin icodec to improve glycemic control in adults with Type 1 diabetes and the balance of risks and benefits in the population;
the role of continuous glucose monitoring devices and measures of glycemic variability to help reduce the risk of hypoglycemia in patients with Type 1 diabetes using insulin icodec;
the proposed dosing and titration regimen and the extent to which the modeling data support alternative dosing strategies; and
the role of insulin icodec in the context of the available treatment armamentarium for patients with Type 1 diabetes.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome