What is Expanded Access?
Expanded Access, sometimes called “Compassionate Use,” is related to an unsolicited physician request for expanded access for an individual patient who meets the eligibility criteria for the Expanded Access Program. Expanded Access is a regulatory mechanism by which drugs that are not yet approved for marketing in a given country (including any new indication of an existing marketed product) are made available at the company’s discretion, to seriously ill patients who have no other comparable or satisfactory alternative therapy for a disease or condition, until regulatory approval in that country is received.
Expanded Access is the use, outside of a clinical trial, of an investigational medical product not yet approved by the regulatory authority where the patient resides or for use in treatment of a new indication of a marketed product.
Criteria for Consideration
Esperion may consider Expanded Access for individual patients, including emergency use requests for investigational medicine outside of a clinical trial, when all of the following criteria are met:
- The patient’s condition is serious or life threatening
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the risks, based on what is known at the time
- Expanded Access will not compromise the clinical development program of the investigational medicine
- Lack of availability of a comparable or satisfactory alternative therapy for the disease or condition
- All other viable treatment options have been exhausted, including clinical trial participation
- The requested drug for the requested indication is available as a commercial product in the region of the request
- Adequate supply exists to support the Expanded Access requests
- There is a regulatory mechanism in the country or region to support Expanded Access
- Government regulations or other legal requirements do not exist that will limit the company’s ability to provide Expanded Access in the requested country