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# UCB’s Rystiggo Approved for Myasthenia Gravis
- URL: https://www.fdaweb.com/ucbs-rystiggo-approved-for-myasthenia-gravis/
- Published: 2023-06-27T12:00:00.000Z
- Updated: 2026-09-14T18:41:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154779

FDA has approved a UCB BLA for Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. The company describes the subcutaneous infusion as a IgG4 monoclonal antibody that binds to the neonatal Fc receptor, resulting in the reduction of circulating immunoglobulin G.

gMG is a rare disease that affects patients with severe muscular weakness that can result in life-threatening weakness in respiration, according to the company. It also causes double vision, drooping eyelids, and difficulty swallowing, chewing and talking.

Approval was based on clinical trial data that showed a statistically significant difference favoring rozanolixizumab compared to placebo in measures of breathing, talking, swallowing, and being able to rise from a chair. The most common adverse reactions were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea, the company says.