Posted by Michael Wonder on 28 Apr 2026
Prothena announces Novo Nordisk obtains fast track designation from the US FDA for coramitug (PRX004) in ATTR amyloidosis with cardiomyopathy
27 April 2026 - Prothena today announced that the US 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.
Novo Nordisk is evaluating coramitug in the on-going Phase 3 CLEOPATTRA clinical trial in approximately 1280 participants with ATTR-CM with primary completion expected in 2029.
