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EFX Expanded Access Policy
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https://akerotx.com/access-policy/
We are currently focused on developing efruxifermin (EFX) for the treatment of nonalcoholic steatohepatitis (NASH), which requires rigorous evaluation of the safety and efficacy of EFX in clinical trials. If these trials provide substantial evidence that EFX is safe and effective for treatment of NASH, we will seek marketing approvals from regulatory health authorities to make EFX available to patients.
We recognize that there may be situations where a patient with a serious or life-threatening condition will not qualify for an Akero-sponsored clinical trial and may seek access to an investigational medicine outside of a clinical trial setting. This process is known as expanded access, treatment use or compassionate use. We are not planning to make EFX available on an expanded access basis at this time. Nonetheless, we will evaluate and respond to expanded access requests on a case-by-case basis, consistent with the policy set forth below.
1. Contact Information. If you have any questions about Akero's expanded access policy or wish to make an expanded access request, please contact info@akerotx.com.
2. Request Procedures. An expanded access request must provide sufficient supporting detail to enable us to evaluate your request. Please also include your contact information so that we may follow up with you directly.
3. General Criteria. Although Akero retains sole discretion in deciding whether to grant an expanded access request, the following criteria will guide evaluation of requests:
o The condition or disease being studied is serious or life-threatening and there are no available alternative treatments;
o The patient is not eligible for an ongoing or planned Akero-sponsored clinical trial;
o There must be sufficient clinical data to identify an appropriate dose for the proposed use;
o The potential benefit to the patient clearly outweighs the collective potential risks;
o There must be adequate supply of the investigational product to meet the needs of the expanded access program without impacting the company's clinical trials;
o The patient meets any other relevant medical criteria for expanded access to the investigational product, as determined by Akero.
4. Anticipated Timing. We anticipate acknowledging receipt of any expanded access questions or requests within 10 business days of receipt.
As authorized by the 21st Century Cures Act, Akero may revise this expanded access policy at any time. Additionally, the posting of this policy by Akero Therapeutics shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
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