Soliris FDA Approval History
Last updated by Judith Stewart, BPharm on March 31, 2025.
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, Neuromyelitis Optica Spectrum Disorder
Soliris (eculizumab) is a complement inhibitor used in the treatment of paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome, myasthenia gravis, and neuromyelitis optica spectrum disorder.
- Soliris is 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. 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 treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. - Soliris is administered by intravenous infusion.
- Soliris comes with a Boxed Warning for an increased risk of serious meningococcal infections. Warnings and precautions include administering Soliris to patients with any other systemic infection, and infusion-related reactions.
- Frequently reported adverse reactions:
- in the PNH randomized trial (≥10% overall and greater than placebo) include headache, nasopharyngitis, back pain, and nausea.
- in the aHUS single arm prospective trials (≥20%) include headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.
- in the gMG placebo-controlled clinical trial (≥10%) in adult patients includes musculoskeletal pain.
- in the NMOSD placebo-controlled trial (≥10%) include upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.
Development timeline for Soliris
Further information
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