eculizumab
Marketed as SOLIRIS.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA125166 | SOLIRIS | 2007-03-16 | ALEXION PHARM |
Manufacturers
ALEXION PHARM
Common denial patterns
- Step therapy requiring ravulizumab (longer-acting) within class
- Meningococcal vaccination not documented (REMS requirement)
- Indication restriction (PNH vs aHUS vs gMG vs NMOSD)
- Site-of-care reduction
Specific notes
Brand: Soliris. C5 complement inhibitor. FDA-approved for PNH, aHUS, generalized myasthenia gravis (anti-AChR+), and NMOSD (anti-AQP4+). REMS-restricted (meningococcal infection risk). Plans increasingly steering to ravulizumab (Ultomiris).
Alexion OneSource: https://www.alexiononesource.com
Frequently asked questions
Why does insurance commonly deny eculizumab?
Step therapy requiring ravulizumab (longer-acting) within class; Meningococcal vaccination not documented (REMS requirement); Indication restriction (PNH vs aHUS vs gMG vs NMOSD); Site-of-care reduction.
When was eculizumab FDA approved?
Earliest FDA approval on record: 2007-03-16.
What brand names are sold as eculizumab?
SOLIRIS.
Is there a patient assistance program for eculizumab?
Yes — Alexion OneSource at https://www.alexiononesource.com.
What's specific to eculizumab?
Brand: Soliris. C5 complement inhibitor. FDA-approved for PNH, aHUS, generalized myasthenia gravis (anti-AChR+), and NMOSD (anti-AQP4+). REMS-restricted (meningococcal infection risk). Plans increasingly steering to ravulizumab (Ultomiris).
Sources
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