Not sexy enough: the uphill battle faced by non‐traditional treatments in the U.S. despite having the most compelling AD results to date

Regulatory approval increases visibility and availability of effective treatment to those suffering from AD. Unfortunately, no clear approval path is available for either of these promising treatments. If Souvenaid becomes available in the U.S., it will be considered one of many general supplements for cognitive health, despite the strong clinical trial data collected to a regulatory standard. Plasmapheresis is a procedure that is not subject to FDA regulation. The AMBAR treatment is available for other indications, and most plasmapheresis treatments are approved by payors if they are recommended by a plasmapheresis board, leading to a challenging regulatory path. Unless the regulatory playing field is leveled for non-traditional treatments, the safest and most promising treatments may be overlooked in favor of sexier treatments like immunotherapies and small molecules.