Novo Nordisk gets FDA fast track status for ATTR heart disease drug
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Prothena Announces Novo Nordisk Obtains Fast Track Designation from the U.S. FDA for Coramitug (PRX004) in ATTR Amyloidosis with Cardiomyopathy
April 27, 2026 4:05 PM EDTCoramitug 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... More
