Expanded access and compassionate use
We believe that carefully designed clinical trials are the safest way to bring you new medicines. Expanded access (also called compassionate use) programs allow people with serious or life-threatening diseases to access investigational therapies outside of clinical trials if they cannot join a trial.
Expanded access and compassionate use programs are typically available for therapies that:
- Are not yet approved in a specific country, or
- Are not approved for a particular disease (also called off-label use).
Prevail does not expect to be able to offer expanded access to our investigational therapies until our clinical trials have finished and the results analyzed. However, we understand that some people may have no other options. For these cases, we have a policy in place to review requests. Please refer to the full policy available for download below.
- Requests will be looked at on an individual basis.
- Requests must be submitted in writing by a licensed physician who is in a treatment relationship with the person.
- Decisions will be made at Prevail’s discretion, based on our published guidelines.
- Prevail will aim to provide a written response to requests in a timely manner.