NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
8/8 — Comprehensive
Priority Review
EMPAVELI (pegcetacoplan) by Apellis Pharmaceuticals is complement inhibitors [moa]. Approved for paroxysmal nocturnal hemoglobinuria, c3 glomerulopathy, membranoproliferative glomerulonephritis and 1 more indications. First approved in 2021.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EMPAVELI (pegcetacoplan) is a subcutaneous complement inhibitor approved in May 2021 for treating C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in adult patients. It works by inhibiting complement activation at the C3 level, a key driver of kidney inflammation in these rare glomerulonephritides. The drug is administered as a solution via subcutaneous injection and represents a first-in-class mechanism for reducing proteinuria in these conditions. EMPAVELI addresses a significant unmet need in rare kidney disease, as these conditions previously lacked targeted immunosuppressive options.
$0.0BPart D
12.6 years to LOEMechanism of Action
Complement Inhibitors
Pharmacologic Class:
Complement Inhibitor
Indications (4)
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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.