Prothena announces Novo Nordisk obtained FDA fast track for PRX004

The company states: “Prothena (PRTA) announced that the 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. 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. ATTR-CM is a progressive disease caused by the deposition of transthyretin as amyloid in the myocardium. Current therapies may slow disease progression but do not clear existing deposits. Coramitug is a humanized monoclonal antibody that targets misfolded transthyretin, designed to promote clearance of transthyretin amyloid through antibody-mediated phagocytosis4. Novo Nordisk (NVO) is evaluating coramitug in the ongoing Phase 3 CLEOPATTRA clinical trial in approximately 1280 participants with ATTR-CM with primary completion expected in 2029. Novo Nordisk gained full worldwide rights to the intellectual property and related rights of the ATTR amyloidosis business and pipeline it acquired from Prothena in July 2021. Under the terms of the acquisition agreement, Prothena is eligible to receive up to $1.2 billion including an upfront payment and upon achievement of clinical development and sales milestones, with $150 million earned to date.”