What is Compassionate Use?
Patients facing serious or life-threatening illness, who have exhausted all available treatment options often want to learn if they can receive early access to investigational drugs that have not been approved by government regulatory agencies such as the Food and Drug Administration (FDA). At Esperion, we believe the best way for patients to access medicines prior to approval is through participation in clinical trials.
Compassionate use is the use, outside of a clinical trial, of an investigational medical product not yet approved by the FDA.
In rare, specific situations, when enrollment into a clinical trial may not be possible, physicians treating patients with serious or life-threatening conditions may seek access to investigational medication; this is commonly referred to as “Compassionate Use” or “Expanded Access.”
Criteria for Consideration
Esperion may consider Compassionate Use 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
- Patient has undergone appropriate standard treatments without success
- All other viable treatment options have been exhausted, including clinical trial participation
- Compassionate Use will not compromise the clinical development program of the investigational medicine
- Adequate supply exists to support both the ongoing clinical trials and prior approved compassionate use requests
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the risks, based on what is known at the time
- There is a regulatory mechanism in the country or region to support Expanded Access
A Prompt Response is Our Goal
We aim to acknowledge the physician’s Compassionate Use request as quickly as possible (generally within 5 business days). All Compassionate Use requests are reviewed on a case-by-case basis. This policy is not a guarantee of access to any ESPERION investigational drug. ESPERION reserves the right to revise or revoke this policy at any time.
For more information regarding the ESPERION Compassionate Use program, treating physicians can submit an email request to expandedaccess@ESPERION.com.