---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-008953"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2023-05-10T23:59:59+00:00"
generated_at: "2026-06-15T05:39:44.727100+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Protalix/Chiesi's ELFABRIO for Fabry disease in adults

## Summary
- FDA approved ELFABRIO (pegunigalsidase alfa-iwxj) for adult Fabry disease patients.
- ELFABRIO is a PEGylated enzyme replacement therapy with a half-life of 78.9 ± 10.3 hours.
- More than 140 patients studied; head-to-head trial showed non-inferior efficacy to agalsidase beta in controlling eGFR decline.
- Most common adverse reactions (≥15%): infusion reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, sinusitis.
- Protalix CEO says approval is a testament to team dedication; Chiesi offers alternative treatment option.

## SEC filing metadata
- accession: 0001558370-23-008953
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2023-05-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000155837023008953/0001558370-23-008953-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000155837023008953/plx-20230510x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-008953
- JSON: https://secwatch.observer/filing/0001558370-23-008953.json
- Plain text: https://secwatch.observer/filing/0001558370-23-008953.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.