Alexion Pharma receives FDA approval for Soliris
- Co announced the FDA approved Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive.
- In the Phase 3 REGAIN study and its ongoing open-label extension study, 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.
- These patients represent approximately 5-10% of all patients with MG.
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