Prothena Announces Novo Nordisk Obtains Fast Track Designation from the U.S. FDA for Coramitug (PRX004) in ATTR Amyloidosis with Cardiomyopathy

• Coramitug is a potential best-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy1-3
• Coramitug is being evaluated by Novo Nordisk in the ongoing Phase 3 CLEOPATTRA clinical trial in ~1280 participants with ATTR-CM; primary completion expected in 2029
• The Fast Track Designation underscores the unmet need within ATTR-CM and could expedite the review of coramitug

DUBLIN--(BUSINESS WIRE)-- Prothena Corporation plc (NASDAQ:PRTA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to coramitug, a potential best-in-class amyloid depleter antibody currently in Phase 3 development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Fast Track Designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious conditions and fill an unmet medical need.