Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AEB071 b.i.d./ everolimus · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| cyclosporine (reduced exposure) / everolimus | ACTIVE_COMPARATOR | - |
| AEB071 300 mg b.i.d. / everolimus | EXPERIMENTAL | - |
| AEB071 200 mg b.i.d. / everolimus | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| cyclosporine (reduced exposure) / everolimus | DRUG | twice daily |
| AEB071 300 mg b.i.d. / everolimus | DRUG | twice daily |
| AEB071 200 mg b.i.d. / everolimus | DRUG | twice daily |
Inclusion criteria: * Patient has been maintained on study drug for 12 months in the core study Exclusion criteria: * Not applicable * Other protocol-defined inclusion/exclusion criteria may apply
AEB071 b.i.d./ everolimus is being studied for use in kidney transplantation. It was evaluated in de novo renal transplant recipients, a population that receives immunosuppressive therapy to prevent organ rejection after transplant surgery. The combination is a small molecule regimen developed by Novartis AG.
AEB071 b.i.d./ everolimus is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this combination in kidney transplantation.
AEB071 b.i.d./ everolimus is in Phase 2 development. The program includes one completed Phase 2 trial with 175 participants. It is an investigational regimen and is not approved for use in kidney transplantation.
AEB071 b.i.d./ everolimus was studied in the Phase 2 trial NCT00820911, titled Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients. The trial enrolled 175 participants across 17 countries and is completed. It was randomized and active-controlled, comparing AEB071 with cyclosporine.