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Kogenate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Kogenate (BAY14-2222) | DRUG | 100 IU/mL (250 IU/vial nominal potency) continuous infusion over 6-11 days in 12 patients. 400 IU/mL (1000 IU/vial nominal potency) continuous infusion over 6-11days in 3 patients. |
Inclusion Criteria: * Severe hemophilia A (FVIII:C \</=1%) * No history of FVIII inhibitor formation and no current evidence of inhibitor antibody (Bethesda Assay \< 0.6 BU) * Elective major surgery requiring at least 6 days of rFVIII-FS therapy * Subjects should have been previously treated with F...
Kogenate is used for hemophilia, a bleeding disorder. It is being investigated for use in patients with hemophilia, specifically in the context of surgeries. The drug is currently in Phase 3 clinical development for this indication.
Kogenate is developed by Bayer AG, a pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in hemophilia patients.
Kogenate is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its use in hemophilia, particularly in surgical settings.
Kogenate has one completed Phase 3 clinical trial, identified as NCT00606060. This trial, titled "BAY14-2222 Continuous Infusion in Surgeries," enrolled 15 male participants aged 12 years and older in Israel. The study was uncontrolled and not randomized or double-blinded.
Kogenate is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for hemophilia. The drug has completed one clinical trial, but it has not yet received regulatory approval for marketing.