Generalized Myasthenia Gravis
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CLINICAL_TRIALS trial_result · 2025-04-18Clinical Trial Update: A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis [Phase 3]
A Phase 3 trial evaluating Rozanolixizumab in adults with Generalized Myasthenia Gravis has completed, and the study results were posted on …
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CLINICAL_TRIALS research · 2025-04-10Clinical Trial Update: Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis [NA]
This clinical trial entry notes a study evaluating the effects of whole-body electrical muscle stimulation during exercise in adults with Ge…
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CLINICAL_TRIALS trial_result · 2025-03-30Clinical Trial Update: An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors [Phase 3]
Open-label Phase 3 study evaluating subcutaneous zilucoplan in generalized myasthenia gravis patients previously treated with IV C5 inhibito…
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FDA approval · 2025-03-12FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for EPYSQLI (eculizumab-aagh), a biosimilar to eculizumab.
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CLINICAL_TRIALS trial_result · 2025-02-28Clinical Trial Update: A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis [Phase 3]
Phase 3 study evaluating satralizumab in generalized myasthenia gravis was terminated. Results from the trial have been posted.
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FDA approval · 2025-01-30FDA Approved: BKEMV — Supplemental Application (Amgen Inc)
FDA approved BKEMV (eculizumab-aeeb) under Amgen’s supplemental application, making a biosimilar to eculizumab available. The product is int…
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CLINICAL_TRIALS research · 2025-01-06Clinical Trial Update: An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis [Phase 1]
An early Phase 1 exploratory study to evaluate GC012F injection for refractory generalized myasthenia gravis, with the trial not yet recruit…
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CLINICAL_TRIALS research · 2024-10-31Clinical Trial Update: A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis. [Phase 2, Phase 3]
A clinical trial update indicating that B007 is being studied for Generalized Myasthenia Gravis in Phase 2/Phase 3, with recruitment ongoing…
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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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CLINICAL_TRIALS research · 2024-09-19Clinical Trial Update: Seronegative Myasthenia Gravis - Efgartigimod IV [Phase 3]
Phase 3 clinical trial update for seronegative generalized myasthenia gravis evaluating efgartigimod IV; the study is currently recruiting.
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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 · 2023-12-12FDA Approved: VYVGART — Supplemental Application (argenx US)
FDA approved a supplemental application for Vyvgart (efgartigimod alfa) submitted by argenx US.
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FDA approval · 2023-10-17FDA Approved: ZILBRYSQ — Original Application (UCB, Inc.)
The FDA approved ZILBRYSQ (zilucoplan) via its Original Application from UCB, Inc., for the treatment of generalized myasthenia gravis.
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CLINICAL_TRIALS trial_result · 2023-08-21Clinical Trial Update: A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis [Phase 3]
Phase 3 clinical trial evaluating Rozanolixizumab in adults with generalized myasthenia gravis has completed. The study results have been po…
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CLINICAL_TRIALS trial_result · 2023-08-21Clinical Trial Update: A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis [Phase 3]
Phase 3 study evaluating long-term safety, tolerability, and efficacy of rozanolixizumab in adults with generalized myasthenia gravis has co…
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FDA approval · 2023-06-26FDA Approved: RYSTIGGO — Original Application (UCB, Inc.)
The FDA approved RYSTIGGO (rozanolixizumab) for the treatment of adults with generalized myasthenia gravis, marking the first approval of th…
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CLINICAL_TRIALS trial_result · 2023-02-28Clinical Trial Update: Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis [Phase 3]
A Phase 3 trial assessing pharmacodynamic noninferiority of Efgartigimod PH20 SC versus IV in generalized myasthenia gravis has completed wi…
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CLINICAL_TRIALS trial_result · 2022-06-27Clinical Trial Update: Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis [Phase 2]
Phase 2 trial evaluating RA101495 in generalized myasthenia gravis completed with posted results.
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CLINICAL_TRIALS trial_result · 2022-05-26Clinical Trial Update: Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis [Phase 3]
Phase 3 safety and efficacy study of Ravulizumab in adults with Generalized Myasthenia Gravis completed and results posted. The trial assess…
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CLINICAL_TRIALS trial_result · 2022-02-16Clinical Trial Update: An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis [Phase 2]
Extension study of MOM-M281-004 (M281) in generalized myasthenia gravis terminated; results posted in 2022.
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CLINICAL_TRIALS trial_result · 2022-02-08Clinical Trial Update: An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness [Phase 3]
Phase 3 trial update on ARGX-113 for generalized myasthenia gravis reports completed results.
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CLINICAL_TRIALS trial_result · 2021-10-27Clinical Trial Update: A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis [Phase 2]
Phase 2 clinical trial evaluating safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of M281 in adults with generalized m…
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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 · 2020-02-05Clinical Trial Update: Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis [Phase 3]
Phase 3 extension study assessing safety and efficacy of eculizumab in refractory generalized myasthenia gravis has completed with results p…
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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…