SOLIRIS
Soliris (eculizumab) is a complement inhibitor indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It is also approved for adult and pediatric patients aged six years and older with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG). Additionally, the drug is used to treat adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). The medication's therapeutic role focuses on reducing hemolysis and inhibiting complement-mediated thrombotic microangiopathy.
How SOLIRIS Works
Eculizumab is a monoclonal antibody that binds to the complement protein C5, preventing its cleavage into C5a and C5b. This action inhibits the formation of the terminal complement complex C5b-9, which otherwise mediates cell destruction. In PNH and aHUS, this process prevents intravascular hemolysis and thrombotic microangiopathy. In patients with gMG and NMOSD, the therapeutic effect is presumed to involve the inhibition of C5b-9 deposition at the neuromuscular junction or other targeted tissues.
Details
- Status
- Prescription
- First Approved
- 2007-03-16
- Routes
- IV (INFUSION)
- Dosage Forms
- INJECTABLE
SOLIRIS Approval History
What SOLIRIS Treats
4 indicationsSOLIRIS is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Generalized myasthenia gravis (gMG)
- Neuromyelitis optica spectrum disorder (NMOSD)
SOLIRIS Boxed Warning
SERIOUS MENINGOCOCCAL INFECTIONS SOLIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 wee...
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS SOLIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying therapy with SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving SOLIRIS are at increased risk for invasive disease caused by Neisseria meningitidis , even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, SOLIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2) ] . WARNING: SERIOUS MENINGOCOCCAL INFECTIONS See full prescribing information for complete boxed warning SOLIRIS increases the risk of serious and life-threatening infections caused by Neisseria meningitidis . Complete or update meningococcal vaccination at least 2 weeks prior to the first dose of SOLIRIS, unless the risks of delaying SOLIRIS outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) re
SOLIRIS Biosimilars
2 FDA-approved1 can be substituted at the pharmacy without calling the prescriber. The other 1 require prescriber approval to switch.
What are biosimilars? Lower-cost alternatives to SOLIRIS with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOLIRIS FDA Label Details
ProIndications & Usage
FDA Label (PDF)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. Limitation of Use SOLIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive. the tre...
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS SOLIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1) ] . Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitor...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.