Investigational Medications Covered By This Policy
Renibus Therapeutics, 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 must be submitted by the licensed treating physician responsible for treating the patient and should include sufficient supporting detail to enable Renibus Therapeutics to evaluate the expanded access request. The requesting physician must also provide their contact information (i.e., address, phone number, e-mail). Each request must relate to a single patient. The requesting physician will be expected to submit an Investigator IND, if appropriate, after Renibus Therapeutics has reviewed the provided information.
Renibus Therapeutics will evaluate and respond to requests on a case-by-case basis, applying the following criteria:
- The patient has a serious or life-threatening disease or condition for which no comparable or satisfactory alternative therapy is available
- The patient does not qualify to participate in any ongoing clinical study sponsored by Renibus Therapeutics
- Sufficient scientific and clinical data are available for both the disease/condition and investigational product to indicate the potential benefits outweigh the potential risks to the patient
- Adequate supply of the investigational product is available to meet the needs of the expanded access program without impairing ongoing clinical trials, clinical development, regulatory approval, or product launch
- The treating physician must open a treatment IND with the FDA
- Use of the investigational product must comply with all local laws and regulations
Renibus Therapeutics will endeavor to acknowledge receipt of any expanded access questions or requests within 10 business days of receipt.
Due to the current limited supply of investigational product, Renibus is not supplying investigational product to individuals outside our clinical trials.