The Food and Drug Administration (FDA) has expanded the indication for Fiasp (insulin aspart injection; Novo Nordisk) 100 Units/mL to include use in insulin infusion pumps to improve glycemic control in adults with type 1 or type 2 diabetes. Previously, the treatment was approved for use by either intravenous infusion by a healthcare professional or by subcutaneous (SC) multiple daily injection (MDI).
The expanded labeling is supported by data from the phase 3 Onset 5 study that compared the efficacy and safety of Fiasp continuous SC insulin infusion to Novolog in adults with type 1 diabetes (N=463). Results of the study showed that Fiasp was found to be noninferior to Novolog based on change from baseline in glycated hemoglobin (HbA1c) after 16 weeks of treatment. In addition, no significant difference in the overall rate of severe or blood glucose‐confirmed hypoglycemia was noted between the treatments (estimated rate ratio 1.00 [95% CI: 0.85; 1.16].
“People living with diabetes are looking for treatment options that fit into their lifestyles and shifting schedules, and for many, an insulin pump is an important part of their regimen,” said Todd Hobbs, VP and US chief medical officer of Novo Nordisk. “This label update will now enable adult patients to use Fiasp in their pumps, which is an important part of our ongoing commitment to patient choice and meeting the needs of people living with type 1 and type 2 diabetes.”
Fiasp is a rapid-acting human insulin analog that is administered at the beginning of the meal or within 20 minutes after starting a meal. The product is available in multiple presentations including 10mL vials for use in insulin pumps or MDI, 3mL FlexTouch for MDI, and 3mL PenFill Cartridge for NovoPen Echo for MDI.
Additionally, the Company has copay and patient assistance programs in place to assist consumers.
For more information visit novonordisk-us.com.