Fiasp(insulin aspart)

Fiasp (insulin aspart) is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. It received initial U.S. approval in 2000, with specific approval for adults with diabetes mellitus (subcutaneous and intravenous) on September 29, 2017, and for continuous subcutaneous insulin infusion (CSII) in adults on October 21, 2019. A pediatric indication was added via Supplemental NDA Approval S-010, and S-011 added CSII use in pediatrics.

In a 26-week randomized, three-armed parallel group trial (Study 4101) in a pediatric population with T1D, meal-time Fiasp demonstrated an HbA1c change from baseline of 0.06% at Week 26, compared to 0.22% for meal-time NovoLog. The treatment difference in HbA1c for meal-time Fiasp versus meal-time NovoLog was -0.17% (95% CI: -0.31%; -0.04%), meeting the non-inferiority margin of 0.4%. Post-meal Fiasp showed an HbA1c change from baseline of 0.35% at Week 26, with a treatment difference of 0.13% (95% CI: -0.01%; 0.26%) compared to meal-time NovoLog.

Regarding safety, severe hypoglycemic episodes were reported as 3 events for meal-time Fiasp, 8 events for post-meal Fiasp, and 4 events for NovoLog. The incidence of blood glucose (BG) hypoglycemia (defined as <56 mg/dL) was 2788/100 PYE for meal-time Fiasp, 2809/100 PYE for post-meal Fiasp, and 2563/100 PYE for NovoLog.