Expanded Access Policy
Lumen Bioscience, Inc. (Lumen) discovers, develops, and manufactures biologic drug candidates for highly prevalent diseases—many of which currently lack effective treatments.
Consistent with Lumen’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting clinical trials to swiftly gain regulatory approvals. We are privileged to collaborate with clinical investigators, researchers and regulatory authorities to develop new, safe, and effective therapies that can benefit those in need.
Where enrollment in a clinical trial is not an option, patients with serious or life-threatening diseases or conditions who have exhausted all other treatment options may receive investigational drug through another option commonly known as “Expanded Access” or “Compassionate Use.”
Per the FDA, Expanded Access may be appropriate when the below criteria are met:
The patient must have a serious or life-threatening illness or condition and no longer respond to or tolerate available treatment options;
The investigational drug must be in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
A benefit-risk analysis, based on available clinical data and the requesting physician’s assessment of the patient’s condition and history, must support use of the investigational drug;
Granting access to the investigational drug should not negatively impact or delay ongoing clinical trials or regulatory review for broader patient access; and
Adequate supply of the investigational drug must be available.
Currently, Lumen does not offer Expanded Access to investigational drugs. We prioritize obtaining sufficient preliminary safety and efficacy data in clinical trials, before considering Expanded Access. Lumen believes that the best way to access our investigational products is to participate in one of our clinical trials.
In the future, Expanded Access may be reassessed for each of Lumen’s investigational drugs as these advance further in clinical trials and more data to support the safety and effectiveness become available. This posting will be updated if there is a change in this expanded access policy. Lumen may revise this policy at any time. If you have additional questions you may contact Lumen at ExpandedAccess@lumen.bio
Patients, caregivers and treating physicians can find more information about Lumen’s clinical studies by visiting www.clinicaltrials.gov and searching for Lumen Bioscience.