Novo Nordisk Receives FDA Label Expansion for Fiasp Insulin Injection, Enabling Use with Insulin Pumps to Improve Glycemic Control in Adults with Type 1 and Type 2 Diabetes

On October 31, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Novo Nordisk, a giant in diabetes treatment, announced that the FDA had approved an expansion of the label for its insulin aspart injection, Fiasp 100 U/mL, allowing the drug to be administered via insulin pumps to improve glycemic control in adult patients with type 1 and type 2 diabetes.

Fiasp is a rapid-acting insulin injection approved by the FDA for market release in 2017. Currently, patients can administer it intravenously or subcutaneously via an insulin pump under medical guidance. An insulin pump consists of a pump unit, a small syringe (reservoir), and an attached infusion set. Battery-operated, this device mimics pancreatic secretory function by continuously delivering insulin subcutaneously at doses tailored to the body’s needs, thereby helping to control blood glucose levels and maintain glycemic stability.

This label expansion is primarily based on the FDA’s review of data from the ONSET 5 clinical trial. The trial confirmed that Fiasp administered via insulin pump has a favorable safety and efficacy profile. Fiasp can be delivered steadily through an insulin pump, and patients demonstrated good tolerability with respect to dosing.

Fiasp is the first and only rapid-acting insulin injection without a recommendation for pre-meal administration, allowing patients to administer it before meals or within 20 minutes after starting a meal. Statistics show that over 350,000 diabetic patients in the United States use insulin pumps, which are small, programmable electronic devices.

Fiasp is available in multiple dosages and represents a new formulation of Novo Nordisk’s insulin aspart injection, NovoRapid. This medication incorporates two new excipients: vitamin B3, which enhances the rate of absorption, and L-arginine, which improves stability, thereby ensuring faster and more effective absorption by the human body. Novo Nordisk states that the glucose-lowering mechanism of Fiasp closely mimics that of the human body under normal physiological conditions and offers superior efficacy compared to conventional insulin aspart. To date, Fiasp has been launched in the United States, the European Union, Canada, Australia, Switzerland, and other international markets.

Novo Nordisk, founded in 1923 and headquartered in Bagsværd, Denmark, is a leading biopharmaceutical company. The company employs 41,600 people across 80 countries worldwide, with its products exported to more than 170 countries and regions. With nearly a century of expertise in diabetes care, Novo Nordisk primarily provides biological products and medical services for patients with diabetes and hemophilia. The company is committed to discovering new methods to improve glycemic control in diabetes, thereby enhancing patients’ health status and quality of life.

Todd Hobbs, Chief Medical Officer at Novo Nordisk, stated, “We are seeking suitable lifestyle and treatment solutions for patients with diabetes, and insulin pumps are a vital component of their treatment regimens. This approval, combining the insulin pump with Fiasp, addresses the medical needs of patients with both type 1 and type 2 diabetes. Novo Nordisk’s mission is to alleviate patient suffering and drive advancements in the field of diabetes care.”

(Compiled by Xu Xiaoxue)