eculizumab
eculizumab: sourced relationships with 1 company · 3 clinical trials tracked · 1 FDA decision.
eculizumab evidence translation
What we can confirm
1 FDA record · 3 tracked trials
What it means
What to watch
Prepared research question
How could eculizumab → AMGN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 1 study sponsors
Related indications
Study sponsors
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| AMGEN INC (AMGN) Reported 2024-05-28 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (3)
A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder
Primary endpoint: Time to adjudicated safety or tolerability failure
Open-Label, Multicenter Study to Assess the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
Primary endpoint: Percentage Change From Baseline in LDH at Week 12
An Open-label, Controlled, Randomized Phase 3 Trial Evaluating 12-month Kidney Function in Highly Sensitized (cPRA ≥99.9%) Kidney Tx Patients With Positive XM Against a Deceased Donor, Comparing Desensitization Using Imlifidase With SoC
Primary endpoint: Mean estimated glomerular filtration rate (eGFR) at 12 months
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with eculizumab?
eculizumab has dated SEC/FDA relationship records for AMGEN INC.
How many clinical trials involve eculizumab?
BioSniper tracks 3 clinical trials involving eculizumab.
What is eculizumab's latest FDA decision?
The most recent tracked FDA decision for eculizumab is Approval for 1 INDICATIONS AND USAGE BKEMV is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. ( 1.1 ) The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. ( 1.2 ) Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). The treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ( 1.3 ) The treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ( 1.4 ) 1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) BKEMV is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 1.2 Atypical Hemolytic Uremic Syndrome (aHUS) BKEMV is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Limitation of Use BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). 1.3 Generalized Myasthenia Gravis (gMG) BKEMV is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. 1.4 Neuromyelitis Optica Spectrum Disorder (NMOSD) BKEMV is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive., dated May 28, 2024.