Access to Investigational Medicines
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. 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 “Expanded Access” or “Compassionate Use.” Expanded Access is the use, outside of a clinical trial, of an investigational medical product (i.e., one that has not been yet approved by the FDA).
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
- Patient has undergone appropriate standard treatments without success
- All other viable treatment options have been exhausted, including clinical trial participation
- Expanded Access 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
We aim to acknowledge the physician’s Expanded Access request as quickly as possible (generally within five (5) business days). All Expanded Access 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 additional information regarding Esperion’s Expanded Access program, treating physicians can submit an email request to email@example.com.