Soliris FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 7, 2020.
FDA Approved: Yes (First approved March 16, 2007)
Brand name: Soliris
Generic name: eculizumab
Dosage form: Injection
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome, Myasthenia Gravis
Soliris is a complement inhibitor indicated for:
- the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
- the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
- the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
- the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Development timeline for Soliris
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