Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2023-05-09

FDA Approved: ELFABRIO — Original Application (Chiesi USA, Inc.)

View source ↗

Summary

The FDA granted approval for ELFABRIO (pegunigalsidase alfa) from Chiesi USA, Inc. as an original enzyme replacement therapy for Fabry disease.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • Elfabrio (migalastat)

Snippet

ORIG AP for ELFABRIO (PEGUNIGALSIDASE ALFA)