What were the pivotal clinical trials that led to the approval of eculizumab for gMG?

Soliris is not expected to affect the aplastic component of anaemia in patients with PNH. Meningococcal Infection. Due to its mechanism of action, the use of ... The treatment is given once a week at a dose of 600 mg for the first 4 weeks, then 900 mg every 2 weeks from the fifth week onwards. A few patients require a ... May 3, 2019 ... In an open-label study involving 14 patients with highly clinically active, AQP4-IgG–positive disease, the use of eculizumab reduced the frequency of relapse. Jun 21, 2024 ... Soliris (eculizumab) is a monoclonal antibody that's approved for patients with atypical hemolytic uremic syndrome (aHUS). It specifically works ... What is Eculizumab · It is a monoclonal antibody. · It is used to prevent the breakdown of red blood cells in adults with paroxysmal nocturnal hemoglobinuria (PNH) ... Jun 2, 2024 ... Both eculizumab and efgartigimod provide more treatment benefits to patients with generalized myasthenia gravis compared with conventional immunosuppressive ... Eculizumab ... Not to be confused with ocrelizumab. Eculizumab, sold under the brand name Soliris among others, is a recombinant humanized monoclonal antibody ... Eculizumab blocks the complement pathway. ▫ Humanised version of anti-C5 antibody, binding specifically to the complement protein. C5 (NHS 2012). Nov 14, 2024 ... The brand names of the eculizumab biosimilars are Bekemv and Epysqli. They are only available for the treatment of PNH and aHUS in countries which have ... 600mg weekly for the first 4 weeks, followed by 900mg for the fifth dose 1 week later, then 900mg every 2 weeks thereafter.