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

Access to Eculizumab for patients with aHUS. NHS England published NICE guidance for the use of Eculizumab for treating in aHUS in January 2015. Eculizumab is a monoclonal antibody that prevents the activation of terminal complement in some autoimmune conditions. ... Eculizumab has a long duration of ... SOLIRIS (eculizumab) is an FDA-approved prescription medicine used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) Soliris 300 mg concentrate for solution for infusion. Active Ingredient: eculizumab. Company: Alexion Pharma UK Ltd. See contact details. Feb 7, 2019 ... Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study About This Drug. Eculizumab-xxxx (Soliris, Bkemv) is used to treat some blood disorders and nerve disorders. It is given in the vein (IV). View the fact sheet ... Eculizumab is a humanized monoclonal antibody directed against C5 of the complement cascade and thereby inhibits the formation of C5a and C5b-9 membrane attack ... Oct 24, 2017 ... The US Food and Drug Administration (FDA) approved eculizumab as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti- ... Mar 21, 2025 ... Eculizumab Biosimilars in PNH: Working Towards Broader Patient Access ... Eculizumab was the first drug approved for the treatment of complement- ... Apr 6, 2025 ... Eculizumab, a humanized anti-C5 monoclonal antibody, has been the standard of care for treating aHUS, and has been shown to be effective in ...