Sponsor Overview
Explore verified public information about Akero Therapeutics, Inc's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
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Expanded Access Intelligence
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Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria Although Akero retains sole discretion in deciding whether to grant an expanded access request, the following criteria will guide evaluation of requests: • The condition or disease being studied is serious or life-threatening and there are no available alternative treatments; • The patient is not eligible for an ongoing or planned Akero-sponsored clinical trial; • There must be sufficient clinical data to identify an appropriate dose for the proposed use; • The potential benefit to the patient clearly outweighs the collective potential risks; • 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; • The patient meets any other relevant medical criteria for expanded access to the investigational product, as determined by Akero. https://akerotx.com/clinical-trials/ Available Therapies via Single-Patient EA Efruxifermin (EFX) for the treatment of nonalcoholic steatohepatitis (NASH)
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