Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 959 · 1 trial · 1 indication
The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).
The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.
| Arm | Type | Description |
|---|---|---|
| T (ABP 959) / R (eculizumab) | OTHER | ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2 |
| R (eculizumab) / T (ABP 959) | OTHER | Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2 |
| Name | Type | Description |
|---|---|---|
| ABP 959 | DRUG | intravenous infusion |
| Eculizumab | DRUG | intravenous infusion |
Inclusion Criteria: * Men and women ≥ 18 years of age. * Historical diagnosis of PNH. * Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab. * Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization. * Lactate dehydrogenase \< 1.5 × the upper limit of no...
ABP 959 is an investigational small molecule being developed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare hematologic disorder. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
ABP 959 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with paroxysmal nocturnal hemoglobinuria.
ABP 959 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of paroxysmal nocturnal hemoglobinuria, a rare blood disorder.
ABP 959 has one completed Phase 3 clinical trial, NCT03818607, which evaluated the efficacy and safety of ABP 959 compared with eculizumab in adult participants with paroxysmal nocturnal hemoglobinuria. The trial enrolled 42 participants across multiple countries, including the United States and several European nations.
ABP 959 is not the same as eculizumab. It is an investigational drug being studied as a potential alternative to eculizumab. The Phase 3 trial NCT03818607 directly compared ABP 959 with eculizumab in patients with paroxysmal nocturnal hemoglobinuria to assess its efficacy and safety.