Myasthenia Gravis Drug Gets FDA Nod

28 Jun 2023 • The U.S. Food and Drug Administration (FDA) has approved rozanolixizumab, under the brand name Rystiggo, to treat adults with generalized myasthenia gravis(gMG) who have antibodies against the acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK) proteins.

Rystiggo is now the only FDA-approved therapy for patients with anti-AChR or anti-MuSK antibodies, the two most common MG-causing antibodies. Anti-MuSK antibodies, occurring in about 6% of patients, often are associated with a more severe and harder to treat form of MG.

As specified in its FDA label, Rystiggo should be administered via a subcutaneous infusion with the help of an infusion pump, once weekly for six weeks. Additional treatment cycles are given based on a patient’s clinical response. The therapy’s recommended dose and infused volume are dependent on a patient’s body weight.

Rystiggo has been shown to be generally safe and well-tolerated, with the most common side effects being headache, diarrhea, fever, and nausea.The treatment is expected to be available to patients in the U.S. in the coming months, the company announced.

Source: Myasthenia Gravis News | Read full story

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