An Expanded Access Program (EAP) allows physicians and patients access to pre-approval, investigational drugs outside of the clinical trial setting. An EAP can also be called a Managed Access Program (MAP), Early Access Program, or Compassionate Use Program (CUP).
These programs are for patients suffering from a serious or life-threatening illness who have no viable treatment options available to them. This means that:
- There are no approved treatments available in the patient’s home country
- If there are approved treatments available, the patient has tried them, and they have been ineffective
- It is not possible to enroll in an active clinical trial
Fundamentally, there must be an unmet clinical need. The provision of a drug through expanded access can only be granted by the drug manufacturer (sponsor) – no regulatory body or third-party provider can facilitate access without sponsor approval. Please refer to either our Patient and Physicians or Sponsors section below for further information related to your EAP needs.