Expanded Access Policy
Renibus Therapeutic, Inc.’s mission is to develop novel therapies targeting unmet medical needs for serious and life-threatening diseases or conditions.
Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561A(f)(2) of the FD&C Act (§21 U.S.C. 360bbb-0) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug. The following is the Renibus Therapeutics policy for evaluating and responding to requests for individual patient access to investigational drugs that are intended to treat serious diseases.
Renibus Therapeutics believes that investigational drugs should be studied in patients as part of clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product and subsequent wider accessibility to patients. We encourage patients to speak with their physicians and to participate in clinical trials. In rare cases when patients with serious diseases are unable to participate in clinical trials and have exhausted all available therapies, Renibus Therapeutics may consider providing an investigational drug outside of a clinical trial. As a general policy, Renibus Therapeutics will not provide investigational drug until sufficient preliminary safety and efficacy information has been obtained in clinical trials, typically following Phase 2 investigation.
As authorized by the 21st Century Cures Act, Renibus Therapeutics may revise this expanded access policy at any time. Additionally, the posting of this policy by Renibus Therapeutics shall not serve as a guarantee of access to any specific investigational drug for any patient.
A treating physician may submit questions or requests regarding expanded access to the following: email@example.com
Additional information may be obtained from the U.S. Food and Drug Administration at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers
Requests should be submitted by the treating licensed physician and should include sufficient supporting detail to enable Renibus Therapeutics to evaluate the expanded access request. Please include contact information so Renibus Therapeutics can follow-up with the physician directly (i.e., address, phone number, e-mail). Requests for expanded access need to be made by the physician responsible for treating the patient, and each request needs to relate to a single patient. The requesting physician would be expected to submit an Investigator IND, if appropriate, after a Renibus Therapeutics review of the provided information. Renibus Therapeutics could provide the investigational drug necessary to support single-person expanded access if such provision does not hinder ongoing clinical trials.
Renibus Therapeutics will evaluate and respond to a request that it receives on a case-by-case basis, applying the following criteria:
- There must be adequate supply of the investigational product to meet the needs of the expanded access program without impairing Renibus Therapeutics’ clinical trials
- There is a good understanding of the indication for which use is requested
- The potential benefit must be considered to outweigh the collective potential risks to the patient
- There must be sufficient clinical data to identify an appropriate dose
- The program must be compliant with local rules and laws
- The program should be discontinued as soon as feasible when the drug is approved for the relevant use
- The treating physician is willing to open a Treatment IND with the FDA
Renibus Therapeutics will endeavor to acknowledge receipt of any expanded access questions or requests within 10 business days of receipt.