Novo Nordisk’s Fiasp gains FDA approval for fast-acting insulin, enhancing diabetes management in US

Novo Nordisk, a leading Danish pharmaceutical company, has secured a significant regulatory milestone with the US FDA approval of its innovative fast-acting mealtime insulin aspart injection, Fiasp 100 Units/mL, for diabetes treatment in adults. This approval positions Fiasp as a key player in the diabetes care market in the United States, building on its existing approvals in Canada and Europe.

A New Step in Insulin Therapy

Fiasp is designed to closely mimic the physiological insulin response of a non-diabetic person around mealtime, thanks to its novel formulation. This new insulin aspart adds two excipients to the existing NovoLog formulation: Vitamin B3 (niacinamide) to enhance absorption speed, and L-Arginine, a naturally occurring amino acid, for stability. These additions aim to deliver a faster insulin action, critical for effective diabetes management.

The approved fast-acting insulin can be administered at the onset of a meal or within 20 minutes after starting to eat, offering flexibility and convenience to users. With its rapid action profile, Fiasp facilitates better blood sugar control, a crucial factor in the long-term management of diabetes.

Fiasp: A Tool for Optimal Blood Sugar Control

Commenting on the FDA approval, Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk, expressed enthusiasm about the expansion of Fiasp’s availability to the US market: “We are very pleased that Fiasp will now also be available to people with diabetes in the US. The fast action profile of Fiasp allows people with diabetes convenient timing in terms of when to take their insulin in connection with meals to achieve the optimal blood sugar control.”

Clinical Trials and FDA Endorsement

The FDA’s approval of Fiasp was based on the results from a comprehensive phase 3 clinical program named ‘onset’, which involved four trials with 2,100 participants suffering from type 1 and type 2 diabetes. These studies demonstrated that Fiasp significantly improves control over blood glucose levels, with a clinically relevant improvement in long-term glucose control (HbA1c).

This regulatory nod follows Fiasp’s demonstrated benefits in enhancing mealtime glucose control, positioning it as a potent tool for individuals needing improved management of their diabetes.

The FDA approval of Fiasp is a promising development in diabetes care, offering patients a more effective and flexible insulin therapy option. This fast-acting formula represents a significant advancement in insulin technology, reflecting ongoing innovations in diabetes treatment that aim to improve quality of life for millions affected by this chronic condition.