Approval granted for once-daily, self-administered treatment in patients with anti-acetylcholine receptor-antibody-positive disease<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b><\/p>\n
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TUESDAY, Oct.\u00a024, 2023\u00a0(HealthDay\u00a0News)\u00a0— The\u00a0U.S. Food and\u00a0Drug\u00a0Administration\u00a0has approved\u00a0Zilbrysq (zilucoplan) for the treatment of adults with generalized myasthenia gravis.<\/p>\n
Zilbrysq is a targeted peptide inhibitor of complement component 5 (C5) and is approved as a once-daily, self-administered, targeted therapy in patients with anti-acetylcholine receptor (AChR)-antibody-positive generalized myasthenia gravis.<\/p>\n
The approval of Zilbrysq is based on results from the phase 3 RAISE study, in which patients were randomly assigned (1:1) to receive daily subcutaneous injections of 0.3 mg\/kg Zilbrysq or placebo for 12 weeks. Significant benefits were seen for the primary end point of improvements in symptoms and functional activities as measured by the Myasthenia Gravis-Activities of Daily Living at week 12. The most common adverse reactions in patients receiving Zilbrysq (\u00e2\u0089\u00a510 percent) were injection site reactions, upper respiratory tract infection, and diarrhea.<\/p>\n
“Until now, people living with generalized myasthenia gravis have only had access to C5 therapy intravenously, which can be inconvenient and time consuming,” Iris Loew-Friedrich, chief medical officer at UCB, said in a statement. “Now \u00e2\u0080\u00a6 we hope a broad population of mild-to-severe adult patients with AChR-antibody-positive generalized myasthenia gravis will be able to have greater independence.”<\/p>\n
Approval of Zilbrysq was granted to UCB.<\/p>\n