Expanded Access Program (EAP)

From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history

Compassionate use or the Expanded Access Program in the United States that allows limited access to unlicensed drugs, for example investigational drugs, under certain conditions.[1]

Similar compassionate use programs exist in other countries, including countries in the European Union.[2]

Serious or life-threatening conditions[edit | edit source]

Compassionate use is typically restricted to only people with life-threatening or serious illness, which the FDA defines as:

Serious disease or condition means a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one."

— Keywords, Definitions, and Resources, Expanded Access — FDA.[3]

Most programs also require patients to have exhausted all available treatment options or to have no available comparable or satisfactory alternatives for the patient. There are typically other restrictions or limitations as well.[4][2]

ME/CFS[edit | edit source]

The drug Ampligen is used by some patients under the US's AMP-511 or earlier programs. It is given by twice-weekly infusions, with the main clinics being Hunter Hopkins in North Carolina, and Daniel Peterson's Sierra Internal Medicine in Nevada.

In clinicial trials for Ampligen a as Karnofsky Performance Score (KPS) of between 20 and 60 has been required. The KPS score goes from 0 (dead) to 100 (excellent health).

Ampligen[edit | edit source]

Ampiglen (rintatolimod) is a drug used by some ME/CFS patients through expanded access.[5]

See also[edit | edit source]

Learn more[edit | edit source]

References[edit | edit source]

  1. "Expanded Access". FDA. March 23, 2021. Retrieved April 13, 2022.
  2. 2.0 2.1 "Compassionate use". European Medicines Agency. Retrieved April 13, 2022.
  3. "Expanded Access | Keywords, Definitions, and Resources". FDA. Retrieved April 13, 2022.
  4. Cite error: Invalid <ref> tag; no text was provided for refs named FDA
  5. Mariani, Mike (September 3, 2019). "A Town for People with Chronic Fatigue Syndrome". New Yorker. Retrieved April 13, 2022.