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FDA Approves Soliris for Generalized MG

Alexion news release; 2017 Oct 23

Alexion Pharmaceuticals, Inc. has announced that the US Food and Drug Administration (FDA) has approved Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive.

Indications: Soliris demonstrated treatment benefits for patients with anti-AchR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing, and breathing. These patients are at an increased risk of disease exacerbations and crises that may require hospitalization and intensive care and may be life-threatening. They represent approximately 5-10% of all patients with MG.

Dosage/administration: For patients with gMG, Soliris therapy consists of 900 mg weekly for the first 4 weeks, followed by 1,200 mg for the fifth dose 1 week later, then 1,200 mg every 2 weeks thereafter. Soliris should be administered at the recommended dosage regimen time points, or within 2 days of these time points.

Adverse reactions: In patients with gMG who are anti-AchR antibody-positive, the most frequently reported adverse reaction observed in the placebo-controlled clinical study (≥10%) was musculoskeletal pain.

Citation:

FDA approves Soliris (eculizumab) for the treatment of patients with generalized myasthenia gravis (gMG). [news release]. New Haven, Connecticut: Alexion Pharmaceuticals, Inc. October 23, 2017. http://news.alexion.com/print/node/699. Accessed October 30, 2017.

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