Approval Probability
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BeneFIX · 1 trial · 1 indication
BeneFIX pharmacokinetic parameter of area under the curve (AUC 0-inf) was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 study).
BeneFIX pharmacokinetic parameter of in vivo recovery was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).
BeneFIX pharmacokinetic parameter of terminal half-life was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).
BeneFIX pharmacokinetic parameter of clearance was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).
BeneFIX pharmacokinetic parameter of mean residence time (MRT 0-inf) was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).
| Arm | Type | Description |
|---|---|---|
| BeneFIX | EXPERIMENTAL | BeneFIX is a recombinant FIX provided in a vial containing 100 IU/mL lyophilized nonacog alfa accompanied with solvent for reconstitution and injection. |
| Name | Type | Description |
|---|---|---|
| BeneFIX | DRUG | BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg. |
Key Inclusion Criteria: * Participated in the previous study "Efficacy and safety of factor IX (FIX) contained in Alphananine in patients with severe hereditary haemophilia B": * Congenital deficiency in Factor IX (FIX) * FIX residual activity of ≤2% of normal * Had required FIX-containing products...
BeneFIX is used for hemophilia B, a bleeding disorder. It is being studied in patients with severe hereditary hemophilia B. The drug is currently in Phase 2 clinical development and is not yet approved for this use.
BeneFIX is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is publicly traded under the ticker symbol GRFS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in hemophilia B.
BeneFIX is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 trial has been completed to assess its safety and efficacy in patients with severe hereditary hemophilia B.
BeneFIX has one completed clinical trial, identified as NCT03091751. This Phase 2 study evaluated the efficacy and safety of AlphaNine versus BeneFIX in patients with severe hereditary hemophilia B. The trial enrolled 13 participants in Bulgaria and was not randomized or double-blinded.
BeneFIX is not the same as AlphaNine. They are separate drugs that were compared in a clinical trial. The study NCT03091751 evaluated the efficacy and safety of AlphaNine versus BeneFIX in patients with severe hereditary hemophilia B, indicating they are distinct treatments.