Prothena Receives FDA Fast Track Designation For Alzheimer’s Disease Treatment

In April 2022, the U.S. Food and Drug Administration (FDA) granted Prothena Corporation plc a Fast Track designation for its PRX012 anti-antibody therapy for the treatment of Alzheimer’s disease (AD). A drug candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the drug candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

Prothena is starting a phase 1 multiple ascending dose (MAD) study, with initiation expected by the end of 2022. Topline data from this phase 1 study is expected . . .