BLAIV (INFUSION)INJECTABLEPriority Review
Approved
Mar 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
69
Data completeness
4/8 — Partial
Priority Review
SOLIRIS (eculizumab) by AstraZeneca is complement inhibitors [moa]. First approved in 2007.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOLIRIS (eculizumab) is a monoclonal antibody complement inhibitor approved in 2007 that blocks the C5 component of the complement cascade, preventing cell lysis and inflammation. It is administered intravenously and treats rare diseases driven by complement-mediated pathology, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The drug represents a foundational therapy in the complement inhibition class.
$223MPart D
LOE ApproachingSOLIRIS faces approaching loss of exclusivity with modest Part D spending, signaling a mature, stabilizing franchise requiring defensive positioning and operational efficiency focus.
Mechanism of Action
Complement Inhibitors
Pharmacologic Class:
Complement Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (69)
Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris
Started Jan 2027
12 enrolled
Paroxysmal Nocturnal Hemoglobinuria
Study of NM8074 in Soliris-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Started Jun 2026
6 enrolled
PNH - Paroxysmal Nocturnal Hemoglobinuria
Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis
Started Aug 2025
6 enrolled
Paroxysmal Nocturnal HemoglobinuriaPNHExtravascular Hemolysis
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD
Started Jan 2025
21 enrolled
NMOSDNeuromyelitis Optica Spectrum Disorders
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG
Started Jan 2025
15 enrolled
Generalized Myasthenia Gravis (gMG)Refractory gMG
Worked on SOLIRIS at AstraZeneca? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.