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Truvelog
Truvelog (insulin aspart) was approved for the following therapeutic use:
Treatment of diabetes mellitus.
Truvelog (insulin aspart) is a biosimilar medicine to NovoRapid Penfill and NovoRapid FlexPen.Insulin lowers blood glucose levels by binding to insulin receptors to increase glucose uptake and inhibit hepatic glucose output. As with all insulins in clinical practice, the duration of action of insulin aspart will vary according to the dose, injection site, blood flow, temperature and level of physical activity.Insulin aspart is equipotent to soluble human insulin on a molar basis. Insulin aspart produces a more rapid and pronounced blood glucose lowering effect than soluble human insulin, due to the faster onset of action. Insulin aspart has a shorter duration of action compared to soluble human insulin after subcutaneous injection. When administered immediately before a meal, the effect of insulin aspart more closely mimics normal physiological postprandial insulin release than soluble human insulin.The onset of action of insulin aspart occurs within 10 to 20 minutes of subcutaneous injection. The maximum effect is exerted between 1 and 3 hours after injection. The duration of action is 3 to 5 hours. Insulin aspart has a more predictable time to peak effect within subjects than soluble human insulin.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Truvelog was considered favourable for the therapeutic use approved.
- 325474, 325475
- 325474, 325475