Aravive, Inc. Expanded Access Policy
Aravive, Inc. is a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease. The following is Aravive’s policy for evaluating and responding to requests for individual patient access to its investigational drugs that are intended to treat serious diseases.
Aravive 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, Aravive may consider providing an investigational drug outside of a clinical trial.
We consider several factors when determining whether to support expanded access for a given investigational drug:
- Will the potential benefit potentially outweigh the collective potential risks to the patient?
- Is there adequate drug supply for both the clinical development program (current and future trials) and broad expanded access?
- Is there enough evidence to reasonably assess that the drug will be safe and effective so that it can be provided to patients under expanded access in an environment that is less controlled than a sponsored clinical trial?
- To meet regulatory requirements, will the safety data be adequately provided to Aravive by a local physician outside of a sponsored clinical trial?
- Is there a good understanding of the indication for which use is requested?
- Will it jeopardize the ongoing development work that Aravive is conducting to bring a therapeutic to market as quickly as possible and to as many patients as possible?
In addition, the program must be compliant with local rules and laws and the treating physician must be willing to open a single-patient (Investigator) IND with the FDA.
A treating physician may submit questions or requests regarding expanded access to the following: firstname.lastname@example.org
Additional information may be obtained from the U.S. Food and Drug Administration at https://www.fda.gov/downloads/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm504494.pdf
Requests should be submitted to email@example.com by the treating licensed physician and should include sufficient supporting detail to enable Aravive to evaluate the expanded access request. Please include contact information so Aravive can follow-up with the physician directly (i.e., address, phone number, e-mail). The requesting physician would be expected to submit an Investigator IND, if appropriate, only after Aravive review of the provided information and approval of the request.
Aravive will endeavor to acknowledge receipt of any expanded access questions or requests within 5-10 business days of receipt.
Aravive may revise this expanded access policy at any time. Additionally, the posting of the policy by Aravive shall not serve as a guarantee of access to any specific investigational drug for any patient.