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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

Jun 27, 2019Approval Alexion Receives FDA Approval of Soliris (eculizumab) for the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder
Oct 23, 2017Approval FDA Approves Soliris (eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (gMG)
Sep 23, 2011Approval Soliris (eculizumab) Approved by FDA for All Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
Mar 19, 2007Approval FDA Approves Soliris (eculizumab) for Paroxysmal Nocturnal Hemoglobinuria
Nov 14, 2006FDA Grants Priority Review for Soliris (eculizumab) BLA for Treatment of Paroxysmal Nocturnal Hemoglobinuria
Sep 20, 2006Alexion Pharmaceuticals Submits Biologics License Application for Soliris (eculizumab)

Further information

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