ATTR Expanded Access Program (EAP)
Physicians looking to enroll patients should email ATTREAP@ionisph.com, or call 1-833-ATTR-EAP (1-833-288-7237). For more information about this expanded access protocol, please visit ClinicalTrials.gov (NCT03400098).
About the EAP
When a patient with a serious illness has exhausted all treatment options and is unable to enter a clinical trial, the US Food and Drug Administration (FDA) may allow the patient to be treated with an investigational drug that is not yet approved for use. Sometimes referred to as “compassionate use,” EAPs help provide these patients with the treatment that they would otherwise not be able to receive.
It’s important to note that clinical trials are still the safest route for providing patients access to investigational treatments because they are well controlled and usually include a large number of patients.
To learn more about available clinical trials, visit ClinicalTrials.gov.
What are the eligibility requirements?
Unfortunately, not every patient who would like to take part is eligible for the ATTR EAP. According to the FDA, participants must meet the following requirements to enroll:
- The patient and a licensed physician are both willing to participate
- The patient’s physician determines that there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition
- The probable risk to the patient from the investigational product is not greater than the probable risk from the disease or condition
- The patient is unable to obtain the investigational drug under an investigational new drug (IND) application and is, therefore, unable to participate in a clinical trial
For more information, please visit the FDA’s Expanded Access (Compassionate Use) page.
If you are a patient looking to enroll in the ATTR EAP, or if you have any questions, please speak with your physician.
The anticipated time to acknowledge receipt of requests for the inotersen Expanded Access Program Early Access Program is one business day.