Zilucoplan (1) – Zilbrysq®

• Clinical trials
  • The MG0009 and MG0010 trials are randomised, double-blind trials, each comparing Zilucoplan with placebo over a period of 12 weeks.

Adults with anti-acetylcholine receptor antibody-positive generalised myasthenia gravis who are eligible for adjunctive therapy to standard treatment

• For adults with anti-acetylcholine receptor antibody-positive generalised myasthenia gravis who are eligible for adjunctive therapy alongside standard treatment, the additional benefit is not proven.
• The pharmaceutical manufacturer submits the results of the pivotal Phase III studies MG0009 and MG0010, as well as meta-analyses of these studies, to demonstrate the additional benefit of Zilucoplan.
• The MG0009 and MG0010 studies, as well as the meta-analyses submitted, are not suitable for the benefit assessment, as they do not allow for a comparison with the appropriate comparator therapy.
• The indirect comparison set out in the annex to Module 4 cannot be used for the benefit assessment either, as the pharmaceutical manufacturer did not carry out or present any data collection, and the processing of the data does not comply with the requirements for the submission of the dossier.
• Furthermore, studies MG0009 and MG0010, as well as the indirect comparison, examine a treatment duration of only 12 weeks.
• The data submitted by the pharmaceutical manufacturer are therefore not suitable for assessing the additional benefit of Zilucoplan compared with the appropriate comparator therapy.
• Overall assessment
  • An additional benefit of Zilucoplan compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.