Introduction: Eculizumab is effective and well tolerated in patients with antiacetylcholine receptor antibody-positive refractory generalized myasthenia gravis (gMG; REGAIN; NCT01997229).We report an interim analysis of an open-label extension of REGAIN, evaluating eculizumab's long … The disease often progresses to the more severe and • Initial phase: 600 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) intravenous infusion every week for the first 4 weeks. • Maintenance phase: 900 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) – Data highlight long-term and real-world efficacy of SOLIRIS ... and generalized myasthenia gravis ... You are encouraged to report negative side effects of prescription drugs to the FDA… The requested dose is within FDA approved labeling Length of Approval: 12 months PRIOR AUTHORIZATION Prior authorization is required for BlueCHiP for Medicare and recommended for Commercial Products POLICY STATEMENT Eculizumab(Soliris) is medically necessary when the criteria above has been met. myasthenia gravis total score AND 5. Soliris SGM – 10/2020. Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome, Myasthenia Gravis Soliris is a complement inhibitor indicated for:. Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. Generalized myasthenia gravis (MG) ... (FDA)-approved prescribing information for complement inhibitors includes a black box warning for increased risk of meningococcal disease. FDA Approved: Yes (First approved March 16, 2007) Brand name: Soliris Generic name: eculizumab Dosage form: Injection Company: Alexion Pharmaceuticals, Inc. Eculizumab (Soliris, Alexion) is currently approved by the FDA for paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and refractory generalized myasthenia gravis. COVERAGE The warning includes a recommendation to administer meningococcal vaccines to patients receiving complement inhibitors. Myasthenia gravis Myasthenia gravis (MG) is a debilitating, chronic and progressive autoimmune neuromuscular disease. ... Generalized myasthenia gravis (gMG) Neuromyelitis optica spectrum disorder (NMOSD) Promptly report to Alexion at 1-888-765-4747 or to the FDA at 1-800-332-1088 Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support On Monday, the company said the FDA had greenlighted the product to treat refractory generalized myasthenia gravis (gMG) patients who are antiacetylcholine receptor (AChR) … Soliris FDA Approval History. It can occur at any age and is characterized by muscle weakness that typically begins with difficulty controlling eye movement.
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