General Criteria: ESSA will evaluate and respond to a request that it receives on a case-by-case basis, applying the following criteria:
- The illness being treated is serious and life threatening, and there are no marketed treatment alternatives
- There must be adequate supply of the investigational product(s) to meet the needs of the expanded access program without impairing ongoing clinical trials
- There is a good understanding of the actions of the investigational drug in the indication for which use is requested, and sufficient clinical data to identify an appropriate dose and treatment regimen, as well as a likelihood of benefit relative to potential risks
In the U.S., physicians may find additional information regarding expanded access to investigational therapies by visiting the U.S. Food and Drug Administration website: Expanded Access: Information for Physicians. Non-U.S. physicians must follow local laws and regulations appropriate for the country originating the request.
This posting of the policy shall not serve as a guarantee of access to any specific investigational drug for any patient. While we our goal is to help patients, please note that we cannot guarantee access to our unapproved medicines, even if we do decide to provide an early access program. Certain circumstances may arise that will prevent us from providing access to the unapproved medicine. For additional information, please contact: firstname.lastname@example.org.