Rystiggo FDA Approval History
Last updated by Judith Stewart, BPharm on June 27, 2023.
FDA Approved: Yes (First approved June 26, 2023)
Brand name: Rystiggo
Generic name: rozanolixizumab-noli
Dosage form: Injection
Company: UCB, Inc.
Treatment for: Myasthenia Gravis
Rystiggo (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive.
- Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease caused by IgG autoantibodies targeting neuromuscular junction proteins and disrupting the ability of the nerves to stimulate the muscles. It is characterized by muscular weakness that can be debilitating and potentially life-threatening.
- Rystiggo contains a drug called rozanolixizumab-noli which is an IgG4 monoclonal antibody that works to treat gMG by binding to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG.
- Rystiggo is administered as a subcutaneous infusion in cycles of once weekly infusions for 6 weeks.
- Warnings and precautions associated with Rystiggo include infections, aseptic meningitis, and hypersensitivity reactions.
- Common adverse reactions include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
Development timeline for Rystiggo
Further information
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