Prothena Biosciences announced that coramitug (previously PRX004) has received Fast Track designation for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), according to details shared recently in a press release.
Fast Track designation aims to accelerate the drug development process for serious diseases with unmet medical need. The designation involves more frequent meetings and regulatory guidance from the U.S. Food and Drug Administration (FDA), as well as potential eligibility for priority review and accelerated approval.
Coramitug is a humanized monoclonal antibody that clears misfolded transthyretin without impacting the normal form of the protein. Novo Nordisk acquired Prothena’s ATTR program in July 2021. They are currently evaluating coramitug in the Phase 3 CLEOPATTRA trial (NCT07207811).