Sponsor Overview
Explore verified public information about Arrowhead Pharmaceuticals, 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.
Unique references curated across 2 content categories.
ClinicalTrials.gov data sources power this status.
Dataset refreshed continuously through Right2Hope ETL pipelines.
Expanded Access Intelligence
Official Statements
Score contribution: 100 — 2 supporting sources.
“Arrowhead’s expanded access to investigational medicines is a means by which investigational medicines are made available, under certain circumstances, to treat patients with serious diseases who are ineligible or unable to participate in an ongoing Arrowhead clinical trial.”
“Arrowhead Pharmaceuticals, Inc. is committed to bringing new investigational medicines to patients with serious diseases as quickly and efficiently as possible. Arrowhead’s expanded access to investigational medicines is a means by which investigational medicines are made available, under certain circumstances, to treat patients with serious diseases who are ineligible or unable to participate in an ongoing Arrowhead clinical trial.”
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria Arrowhead requires the following criteria be met for a request to be considered: • The investigational medicine must be part of an active clinical development program, • Access to the medicine will not compromise clinical trials or the regulatory pathway, • There is substantial scientific evidence to support the benefit risk profile of the investigational product for its intended use, • Sufficient supply of the investigational medicine is available, and • It is logistically possible to safely administer the investigational medicine outside of a clinical trial setting The patient and the treating physician must also meet the following criteria to be considered by Arrowhead for access to an investigational medicine: • He/she has a serious or immediately life-threatening disease • He/she lacks other currently available therapeutic options • He/she is unable to join an active clinical trial of the investigational product • His/her treating physician believes there is potential for the patient under consideration to reasonably expect benefit from the treatment Available Therapies via Single-Patient EA ARO-AAT Injection For the treatment of alpha-1 antitrypsin deficiency associated liver disease. Disease/Category-Specific EA Policies/Criteria https://arrowheadpharma.com/wp-content/uploads/2019/03/Compassionate-Use-Expanded-Access.pdf
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