Delivering vital therapies to patients through Expanded Access Programs

Expanded Access Programs (EAPs), sometimes known as Managed Access Programs (MAPs), allow pharmaceutical sponsors to offer patients their pre-approval investigational drugs outside of a clinical research setting in an ethical, controlled, and compliant manner.

These programs, which the drug development sponsor runs, are available only for critical life-threatening conditions for which there are limited alternative treatment options available. As well as the benefits to patients, such programs allow the biopharmaceutical company to develop
relationships with key opinion leaders (KOLs), patients, patient groups and regulatory agencies before marketing authorisation and commercialization. Typically, data collected in these studies is used for pharmacovigilance reporting and regulatory communications and applications.