Drugs / ABP 959
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2023-08-03 | “The FDA accepted the U.S. Biologics License Application for ABP 959, an investigational biosimilar to SOLIRIS ® (eculizumab).” amgen.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03818607 | Jan 2019 → Jul 2022 | paroxysmal nocturnal hemoglobinuria | Amgen | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-12-08 | Amgen | Results AMGEN HIGHLIGHTS HEMATOLOGY PORTFOLIO AT ASH 2023 amgen.com ↗
Efficacy of Parallel and Crossover Analysis As Well As Pharmacokinetic Similarity Were Confirmed between ABP 959 and Eculizumab Reference Product in Patients with PNH |
| 2022-08-23 | Amgen | Results AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 959, BIOSIMILAR CANDIDATE TO SOLIRIS® (ECULIZUMAB) amgen.com ↗
The safety and immunogenicity profile of ABP 959 was comparable to SOLIRIS. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-12-08 | Amgen | AMGEN HIGHLIGHTS HEMATOLOGY PORTFOLIO AT ASH 2023 amgen.com ↗ |
| 2022-08-23 | Amgen | AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 959, BIOSIMILAR CANDIDATE TO SOLIRIS® (ECULIZUMAB) amgen.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABP 959 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03818607 ↗ |
| Route | Intravenous | “intravenous infusion” NCT03818607 ↗ |