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

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA