Reven Expanded Access Policy for Healthcare Professionals and Patients (March 2020)
At Reven, LLC (Reven) we are committed to providing a novel treatment option to patients living with serious diseases. To do this, Reven conducts clinical trials to assess the safety and efficacy of its investigational new drug product, RJX, which may allow us to obtain the necessary regulatory approvals to provide patients with commercial access.
Reven maintains that participating in clinical trials is the best way for patients to access drug products prior to approval however, in some circumstances, patients with serious diseases or conditions may seek special access to investigational drug products. This special access to investigational drug products is referred to as “Expanded Access” or “Compassionate Use”. Patients who seek access to investigational drug products outside of an established clinical study and prior to health authority marketing authorization may wish to do so for a variety of reasons inclusive of: standard treatments have failed, they cannot tolerate drug products commercially available for their condition, they are not eligible to participate in a clinical study, and/or because there are no comparable or satisfactory therapy options available outside of a clinical trial.
Because of the need to focus development efforts on clinical trials that could support regulatory approval, Reven generally will not provide access to its investigational new drug product via Expanded Access. However, Reven is willing to evaluate requests for such access in the United States from qualified physicians, including consideration of the following:
- Whether the disease or condition is serious or life-threatening.
- Whether the indication for which the medication is requested is consistent with and not likely to interfere with Reven’s overall clinical development plan.
- Whether there are adequate alternative therapies or clinical trials available.
- Whether there is substantial scientific evidence to support both the safety and the efficacy of the investigational drug product for the indication requested and enough clinical data are available to identify an appropriate dose.
- Whether the potential benefit to the patient justifies the potential risks of the treatment with the investigational drug product and those potential risks are not unreasonable in the context of the disease or condition to be treated.
- Whether allowing expanded access or compassionate use will interfere with the initiation, conduct, or completion of clinical trials that could support marketing approval of the investigational drug product for the disease or condition for which expanded access or compassionate use is sought.
- Whether adequate and appropriate drug supply is available.
- The qualifications of the physician, including experience with the therapy or expertise with the specific disease or condition and ability to administer and monitor the patient’s safety.
- Whether the potential patient and/or their guardian is willing and able to provide informed consent and comply with the safety and monitoring requirements defined by Reven.
All questions and requests regarding Reven’s Expanded Access Program should be submitted to Reven by email: ExpandedAcces@reven.com. In the case of requests by treating physicians, the email should contain enough information for Reven to evaluate the request consistent with this policy. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, if applicable, and to comply with all other safety, monitoring, and patient consent requirements defined by Reven. At this time, requests for Expanded Access may only be made by licensed US physicians. Reven will acknowledge receipt of requests within 5 business days. Reven cannot guarantee that their investigational drug product will be available for an Expanded Access request. If granted, access will be for a designated time period and then another request must be submitted and reviewed to continue the program.
At any point Expanded Access can cease being made available at the discretion of Reven. This policy may change without notice.
Further information about Reven’s clinical trials is available at: ClinicalTrials.gov.