FDA approves Rystiggo for myasthenia gravis

People with myasthenia gravis now have a new treatment option that may offer better and faster symptom improvement and less discomfort when administering the drug.

On June 27, the US Food and Drug Administration (FDA) approved the monoclonal antibody Rystiggo (rozanolixizumab-noli) for generalized myasthenia gravis (gMG) in adult patients with either of the two most common subtypes of the disease, anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive MG, according to a press release from UCB, the manufacturer of the drug.

This is an exciting time for myasthenia gravis patients. This approval means U.S. patients will have access to a new, more targeted treatment that will act quickly to improve their status and lives, says Vera Bril, MD, professor of medicine and director of the neuromuscular branch of the University of Toronto and University Health Network of Toronto and principal investigator of the Mycaring study, the randomized, double-blind, placebo-controlled Phase 3 study that supported the approval of Rystiggos.

The FDA approval of rozanolixizumab marks a significant milestone in the management of patients with gMG, highlighting the crucial role of FcRn blockers in their treatment, says Rachana Gandhi Mehta, MBBS, assistant professor of neurology at Wake Forest University School of Medicine and a neurologist at Atrium Health Wake Forest Baptist, both in Winston Salem, North Carolina. Dr. Mehta was not involved in the drug’s development.

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