SANOFI AVENTIS US — Apidra FDA Review (NDA/BLA 021629, 2020)
Sanofi · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details the supplemental new drug application for Sanofi Aventis' Apidra SoloStar, an insulin glulisine injection. The report covers the approval process, including regulatory history and concerns regarding differentiation from Lantus SoloStar, which led to a differentiation study and multiple review cycles. The study confirmed that color-differentiated pens significantly reduced medication errors. The document outlines Apidra's safety profile, common adverse reactions, efficacy data from clinical trials in various patient populations, and pharmacokinetic properties. It also provides comprehensive patient counseling information, including self-management, handling special situations, avoiding medication errors, and specific instructions for pump users and storage. The approval recommendation for Apidra SoloStar was granted after addressing all regulatory concerns.
Key findings — cited to the page
| Severe symptomatic hypoglycemia events per month per patient (Type 1 Diabetes Adults, Apidra Post-meal) | 0.05 | Apidra · p.27 |
| Approval Date | 02/24/2009 | Apidra SoloStar · United States · p.1 |
| Indication | APIDRA is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. | Apidra · United States · p.1 |
| Severe symptomatic hypoglycemia events per month per patient (Type 1 Diabetes Adults, Apidra Pre-meal) | 0.05 | Apidra · p.27 |
| Dosage form strength | 100 units/mL | Apidra · p.21 |
| Dosage form | 10 mL vials | Apidra · p.21 |
| Dosage form | 3 mL cartridge system for use in OptiClik ® (Insulin Delivery Device) | Apidra · p.21 |
| Maximum dose | 80 units | SoloStar · p.172 |
| Dosage form | 3 mL SoloStar® prefilled pen | Apidra SoloStar · p.21 |
| Hypoglycemic seizure rate (Apidra) | 6.1 % | Apidra · p.27 |
| Hypoglycemic seizure rate (Lispro) | 4.7 % | Lispro · p.27 |
| Severe symptomatic hypoglycemia events per month per patient (Type 1 Diabetes Adults, Regular Human Insulin) | 0.13 | Regular Human Insulin · p.27 |
Source: Sanofi ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →