Expanded Access Policy
Alpine is committed to bringing innovative new drug therapies to patients with serious or life-threatening diseases or conditions. Participation in a clinical trial is currently the most appropriate way to access our investigational therapies. However, Alpine will consider providing a requesting physician with pre-approval access (expanded access) to ALPN-101.
Expanded access provides a potential way for a patient with a serious or life threatening disease or condition to receive an investigational medical product for treatment outside of a formal clinical trial when no comparable, satisfactory, or standard therapies are available.
Investigational medical products, such as ALPN-101, are investigational drugs that have not been approved by the United States FDA or other global regulatory authorities. Physicians and patients should consider all possible risks and benefits when seeking expanded access to an unapproved investigational drug since the risk: benefit profile of the investigational drug is not yet fully established.
Expanded Access Program for ALPN-101
Alpine is committed to evaluating all expanded access requests in a fair and equitable manner. For a patient to be evaluated for participation in the ALPN-101 Expanded Access Program, a treating physician, on behalf of a specific patient, should submit a request to Alpine. The request should be sent by email to [email protected]. The request will be reviewed by Alpine within 24 hours.
Alpine will evaluate an expanded access request based on a variety of factors, which include but are not limited to:
- The request for expanded access is submitted by a treating physician, who is appropriately licensed;
- The patient’s condition is serious or life-threatening and there is a reasonable potential that the investigational drug has the potential to provide a benefit to the patient with an acceptable level of risk;
- Participation in a clinical trial is not an option, either because the patient is not eligible to enroll or because there are no appropriate ongoing clinical trials;
- The proposed dose of the investigational drug is within the existing dose range for which human safety data are available;
- The investigational product is available for treatment use without compromising supplies that have been designated for other uses.
Requests will be considered on a case-by-case basis. If a request for expanded access is granted, the requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring, and safety reporting.
Alpine cannot guarantee access to ALPN-101. Alpine retains all rights to approve or decline all expanded access requests in its full discretion. In line with the 21st Century Cures Act (pdf: Pub.L. 114 – 255), Alpine may revise this policy at any time.