Drug intelligence / Profile preview

AMAG-423

Development stage
Unknown
Lead developer
Azurity Pharmaceuticals
Modality
Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

AMAG-423 is an investigational **digoxin immune Fab ovine** biologic developed by **AMAG Pharmaceuticals** for the treatment of **severe preeclampsia in pregnant women**. It is a polyclonal antibody Fab preparation repurposed from the approved digoxin-toxicity antidote active ingredient used in DigiFab, but in this program it was intended to neutralize **endogenous digitalis-like factors** that are elevated in preeclampsia. By binding circulating digitalis-like factors, AMAG-423 was designed to reduce their biologic activity and potentially improve maternal disease manifestations in severe preeclampsia. The program received **FDA orphan drug** and **fast track** designations and advanced into a **Phase 2b/3a** trial before later becoming part of the Covis portfolio following the acquisition of AMAG Pharmaceuticals.

Other names
digoxin immune Fabdigoxin immune Fab ovine
02

Targets

ATP1A (Sodium/potassium-transporting ATPase)

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