At Reata, we are devoted to providing transformative therapies to people facing rare and life-threatening diseases. We seek to provide these therapies to the broadest group of patients possible by engaging in clinical research with the goal of obtaining regulatory approval of our products. Clinical trials allow us to evaluate investigational new treatments in order to generate the safety and efficacy data needed to obtain such approval.
We believe the best way for patients to access medicines prior to approval is through participation in clinical trials. However, in some rare and very specific circumstances when enrollment into a clinical trial is not feasible, physicians caring for patients with serious or life-threatening conditions or diseases may seek special access to investigational medicines (referred to as compassionate use or also known as expanded access). Only in these rare and very specific circumstances patients may be able to receive investigational medicines outside the clinical trial process through a compassionate use program. Reata will consider individual compassionate use requests to an investigational medicine outside of a clinical trial based on an assessment of the following:
- Scientific/clinical rationale for the proposed use
- Potential for inclusion of the patient in an ongoing Reata clinical study
- Fit with Reata’s research objectives
- Availability of clinical drug supplies to support the request
- Experience of the investigator with the requested drug
A licensed physician must submit the request for compassionate use in writing. The request must contain, at a minimum, the following information:
- Demographics of the proposed compassionate use patient
- Relevant medical history, including all therapies administered to date for the relevant indication
- Assessment of the patient’s prognosis
- Reason for requesting compassionate use
- Proposed treatment plan under compassionate use
- Statement that the physician (and the associated institution, if relevant) is able and willing to prepare and submit to the FDA the required regulatory documents to obtain a treatment IND for the patient
- Statement that the physician (and the associated institution, if relevant) will obtain informed consent from the patient and approval of the appropriate IRB prior to initiating treatment
An internal team at Reata will review the request. If the internal team determines that it is not in the best interest of Reata or the patient to support the compassionate use request, a communication will be sent to the requesting physician that the request for compassionate use has been denied. There is no appeal process for a request that has been denied by the internal team.
If the internal team supports the request for compassionate use, the request will be submitted to Reata’s Board of Directors. A communication will be sent to the requesting physician as to the Board of Directors’ denial or approval of the request for compassionate use. There is no appeal process for a request that has been denied by Reata’s Board of Directors.
A treating physician may submit a request for compassionate use to, or discuss eligibility or other questions by submitting an online form. All requests will be acknowledged within 5 business days after receipt of the written request and the completed application documentation. Reata is committed to prompt evaluation of a request after such acknowledgement.
Information about Reata’s ongoing clinical trials can be found at https://clinicaltrials.gov or http://www.reatapharma.com/clinical-trials.
This policy is not a guarantee of access to any Reata investigational drug. Reata reserves the right to revise or revoke this policy at any time.