Millendo’s mission is to develop transformative treatments for rare endocrine diseases where there is a significant unmet medical need. In order to bring safe and effective treatments to patients, we conduct clinical trials during which we collect data about our investigational drugs. These data are then submitted to regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that the treatments can be approved for patient use. The most appropriate way of accessing Millendo’s investigational drugs is through participation in one of our clinical trials. However, we acknowledge that there are patients with these rare endocrine diseases who do not qualify for enrollment in a currently active clinical trial and who may benefit from access to our investigational drugs. Therefore, Millendo will evaluate on a case-by-case basis all requests for access to our investigational drugs.
Criteria Used by Millendo to Evaluate Requests for Expanded Access:
A number of important factors must be considered when evaluating a request for Expanded Access. A patient will be considered for Expanded Access when the following criteria are met:
The request for Expanded Access is submitted by the treating physician, who is appropriately licensed;
The patient’s condition is serious or life-threatening;
Participation in a clinical trial is not an option, either because the patient is not eligible to enroll or because there are no appropriate ongoing clinical trials;
There is agreement between the patient’s treating physician and the medical lead at Millendo that use of the investigational drug has reasonable potential to provide a benefit to the patient with an acceptable level of risk;
The proposed dose of the investigational drug is within the existing dose range for which human safety data are available; and
The drug product required is available for treatment use without compromising supplies that have been designated for other uses.
Please submit requests for Expanded Access using the form provided on the Contact Us page.