ATTR Expanded Access Program (EAP)

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:

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.

If you are a physician looking to enroll a patient in the ATTR EAP, please submit a request to attreap@ionisph.com or call 1-833-ATTR-EAP (1-833-288-7327).

The anticipated time to acknowledge receipt of requests for the inotersen Expanded Access Program Early Access Program is one business day.

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