Atypical Hemolytic Uremic Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-10-23FDA Approved: BKEMV — Supplemental Application (Amgen Inc)
The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, updating its labeling and indications for this eculizuma…
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FDA approval · 2024-09-19FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)
The FDA approved a supplemental application for SOLIRIS (eculizumab) filed by Alexion Pharmaceuticals, resulting in updated labeling that ma…
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FDA approval · 2024-07-19FDA Approved: EPYSQLI — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved EPYSQLI (eculizumab-aagh) from Teva as a biosimilar to Soliris, for the same indications as the reference product.
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FDA approval · 2024-05-28FDA Approved: BKEMV — Original Application (Amgen Inc)
FDA approved BKEMV (eculizumab-aeeB), a biosimilar to eculizumab, developed by Amgen. The approval covers the same indications as the refere…
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CLINICAL_TRIALS trial_result · 2023-09-21Clinical Trial Update: Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients [Phase 2]
Phase 2 clinical trial update evaluating eculizumab for thrombotic microangiopathy/atypical hemolytic uremic syndrome–associated multiple or…
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FDA approval · 2021-06-07FDA Approved: ULTOMIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)
FDA approved a supplemental application for ULTOMIRIS (ravulizumab) from Alexion Pharmaceuticals, reflecting an update to labeling or expans…
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FDA approval · 2020-10-09FDA Approved: ULTOMIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)
The FDA approved a supplemental application for Ultomiris (ravulizumab) submitted by Alexion Pharmaceuticals, resulting in changes to the la…
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CLINICAL_TRIALS trial_result · 2020-09-16Clinical Trial Update: Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS) [Phase 3]
Phase 3 trial in children and adolescents with atypical hemolytic uremic syndrome (aHUS) completed, with results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-02-10Clinical Trial Update: Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS) [Phase 3]
Phase 3 trial of ALXN1210 in treatment-naïve adults and adolescents with atypical hemolytic uremic syndrome has completed with results poste…
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CLINICAL_TRIALS trial_result · 2020-01-02Clinical Trial Update: Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment
A terminated clinical trial investigating predictors of disease progression in atypical hemolytic uremic syndrome, including genetics and bi…
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CLINICAL_TRIALS trial_result · 2019-12-06Clinical Trial Update: Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS [Phase 4]
Phase 4 study evaluating an algorithm-based strategy for discontinuing eculizumab in children and adults with atypical hemolytic uremic synd…
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FDA approval · 2019-06-27FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)
The FDA approved a supplemental application for SOLIRIS (eculizumab) filed by Alexion Pharmaceuticals Inc., updating labeling to reflect the…
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CLINICAL_TRIALS withdrawal · 2019-02-19Clinical Trial Update: The Role of Microparticles as a Biomarker
A University of Rochester trial evaluating microparticles as a biomarker for atypical hemolytic uremic syndrome and thrombotic thrombocytope…
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FDA approval · 2018-12-21FDA Approved: ULTOMIRIS — Original Application (Alexion Pharmaceuticals Inc.)
FDA approved Ultomiris (ravulizumab) through the original application for treatment of certain complement-mediated diseases, including parox…
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CLINICAL_TRIALS withdrawal · 2017-11-14Clinical Trial Update: Complement Inhibition in aHUS Dialysis Patients [Phase 2]
A Phase 2 trial evaluating a complement inhibitor in atypical hemolytic uremic syndrome patients on dialysis has been terminated.
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CLINICAL_TRIALS trial_result · 2017-03-10Clinical Trial Update: The Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS) [Phase 2]
Phase 2 trial assessing the safety and efficacy of eculizumab in Japanese patients with atypical hemolytic uremic syndrome (aHUS) has comple…
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CLINICAL_TRIALS trial_result · 2017-02-24Clinical Trial Update: aHUS Observational Long Term Follow-Up
An observational long-term follow-up trial for atypical hemolytic uremic syndrome has been terminated.
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CLINICAL_TRIALS trial_result · 2015-04-29Clinical Trial Update: An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome [Phase 2]
This update reports results from an open-label, multicenter Phase 2 trial of eculizumab in pediatric patients with atypical hemolytic-uremic…
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CLINICAL_TRIALS trial_result · 2015-04-24Clinical Trial Update: An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome [Phase 2]
Phase 2 open-label, multi-center trial of eculizumab in adults with atypical hemolytic uremic syndrome has completed and results were posted…
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CLINICAL_TRIALS trial_result · 2015-01-26Clinical Trial Update: Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS) [Phase 2]
Phase 2 open-label trial evaluating eculizumab in adult patients with plasma therapy-sensitive atypical Hemolytic Uremic Syndrome; results w…
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CLINICAL_TRIALS trial_result · 2015-01-26Clinical Trial Update: Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS [Phase 2]
Open-label Phase 2 trial of the complement inhibitor eculizumab in adolescent patients with plasma therapy–sensitive atypical hemolytic urem…
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CLINICAL_TRIALS trial_result · 2014-12-03Clinical Trial Update: Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUS [Phase 2]
This ClinicalTrials.gov update reports results from a Phase 2 open-label controlled trial of eculizumab in adolescents with plasma-therapy-r…
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CLINICAL_TRIALS trial_result · 2014-12-01Clinical Trial Update: Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUS [Phase 2]
Phase 2 open-label trial of eculizumab in adult patients with plasma therapy-resistant atypical hemolytic uremic syndrome completed, with re…
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CLINICAL_TRIALS trial_result · 2012-12-24Clinical Trial Update: To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients
This update reports on the safety and tolerability of eculizumab in two Japanese patients with atypical hemolytic uremic syndrome (aHUS). Th…
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FDA approval · 2012-12-21FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)
FDA approved a supplemental application for SOLIRIS (eculizumab) submitted by Alexion Pharmaceuticals, resulting in changes to the product l…