WEP Clinical, Your “trusted partner” for Expanded Access Programs
A Expanded Access Program (EAP) allows physicians and patients access to much needed medicines when there are no other viable options left. These may be investigational therapies as well as drugs not available in the patients country and the ultimate intention is to treat unmet clinical need.
An EAP can also be known as an Managed Access Program (MAP), Early Access Program, Compassionate Use Program, Named Patient Program (NPP). Essentially they all describe the provision of an unlicensed medication from another country to patients that have no local alternative.
EAPs fall broadly into two main groups:
Pre-Approval EAPs provide medicines:
That are still in development and not yet approved
For patients that are ineligible for an existing clinical trial
For patients that cannot access an ongoing clinical trial
For trial patients needing continued treatment after the trial has ended
Post-Approval EAPs provide medicines that:
Have been approved but are not yet commercially available
Have been approved in one country but not in another
Have been discontinued but some patient cohorts still require access to them. These can be provided from another country where they are still available