Iptacopan

(Fabhalta®)

Fabhalta®

Drug updated on 12/11/2024

Dosage FormCapsule (oral; 200 mg)
Drug ClassComplement factor B inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)
  • Indicated for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) 1.5 g/g.

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • The abstract does not provide detailed effectiveness outcomes for iptacopan (FABHALTA) in the treatment of eculizumab-refractory Paroxysmal Nocturnal Hemoglobinuria (PNH) but mentions its inclusion in a systematic review.
  • No direct comparisons or specific data on the effectiveness of iptacopan relative to other drugs like pegcetacoplan or danicopan are mentioned, and there are no subgroup-specific effectiveness outcomes provided.
  • There is no safety information available in the reviewed documents regarding FABHALTA for the treatment of eculizumab refractory PNH.
  • There is no population types or subgroups information available in the reviewed documents regarding FABHALTA for the treatment of eculizumab refractory PNH.

Product Monograph / Prescribing Information

Document TitleYearSource
Fabhalta (iptacopan) Prescribing Information.2024Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses