Expanded Access Policy
Arbutus is dedicated to developing new therapies for the treatment of chronic hepatitis B. Expanded Access (sometimes referred to as “Compassionate Use”) is a potential pathway for patients with a serious or life-threatening disease or condition to obtain investigational products outside of a clinical trial. At this time, Arbutus does not have an Expanded Access program for any of its investigational therapies.
We believe that enrolling patients in our ongoing and future clinical trials is the most appropriate means of generating the evidence required to demonstrate safety and effectiveness of our therapies to support regulatory approval for broader patient access. For more information about our current clinical trials and eligibility requirements please visit www.clinicaltrials.gov.
We recognize people may be interested in accessing our investigational therapies prior to regulatory approval or outside of a clinical trial setting through Expanded Access programs. Arbutus will continue to evaluate the possibility of providing an Expanded Access program in the future.
In the future, if Arbutus considers granting Expanded Access requests on a case by case basis, then it will provide more detail on the process and timing for acknowledging and responding to such requests.
Arbutus conducts periodic reviews of its policies to ensure conformity with applicable laws and regulations. As our development programs progress, we reserve the right to revise this policy at any time.