89bio is dedicated to developing new potential treatments for serious and life-threatening diseases. We are committed to efficiently advancing our investigational products through the clinical development process. It is our mission to bring innovative medicines that, if approved, would have a positive impact on patient health, and to serve patients, patient families, and patient communities through education, empathy, and awareness.
We are currently focused on enrolling and conducting the clinical trials necessary to apply for, and potentially gain, regulatory approvals to make our medicines available to patients. We are privileged to collaborate with clinical investigators and patients who participate in our studies. We believe this approach is best suited to help us develop products that could help patients, if approved.
We recognize that there are seriously ill patients who are not and will not be eligible for 89bio-sponsored clinical trials and do not and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. However, at this time, 89bio does not provide any of its investigational product candidates, including pegozafermin, via expanded access (also referred to as compassionate use). We have considered many factors in arriving at this determination, including making reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting, and our ability to maintain supply for clinical trials, from enrollment to completion. In the event that 89bio decides to consider expanded access use for any of its investigational product candidates, including pegozafermin, in the future, we will evaluate and respond to each expanded access request on a case-by-case basis using criteria that ensure such requests are considered in a fair and consistent manner.
1. Contact Information. If you have any questions about 89bio’s expanded access policy or wish to make an expanded access request, please contact email@example.com.
2. Request Procedures. A licensed physician or healthcare provider (HCP) must initiate the expanded access request and include sufficient supporting detail to enable us to evaluate the request. The request must include the physician’s or other HCP’s contact information so that we may respond or follow up for further information.
3. General Criteria. While 89bio retains sole discretion in determining whether to grant an expanded access request, the following criteria will guide 89bio’s evaluation of expanded access requests:
4. Anticipated Timing. We anticipate acknowledging receipt of any expanded access request within ten (10) business days from its receipt. Further information about 89bio’s clinical trials is available at www.clinicaltrials.gov.
As authorized by the 21st Century Cures Act, 89bio may revise or cancel this expanded access program at any time. Additionally, the posting of this program and its criteria in no way serves as a guarantee of access to any investigational product by any individual patient, physician, or HCP. Finally, 89bio reserves the right to discontinue the provision of investigational product to a patient at any time.