Expanded access

AAVantgarde Expanded Access Policy

AAVantgarde’s Commitment is to Develop Effective Therapies in a Robust and Rapid Path

We are committed to a rigorous clinical development process to evaluate the safety and efficacy of our investigational gene therapy candidates through clinical trials, while minimizing safety risks to patients.

We recognize that there are situations when a patient with a serious condition will not qualify for an AAVantgarde-sponsored clinical trial and may seek access to an investigational medicine outside of a clinical trial setting, also known as expanded access, treatment use or compassionate use.

At this time, AAVantgarde is focused on conducting clinical trials with the goal of achieving regulatory approval to make these therapies broadly available to patients.  For this reason, we are not accepting applications for expanded access.

Patients and families with questions can contact AAVantgarde’s Patient Advocacy team at patientadvocacy@aavantgarde.com. Physicians with questions can contact our Medical Affairs team at medinfo@aavantgarde.com.

Further information on available AAVantgarde clinical trials can be found at our website, www.aavantgarde.com, or at the U.S. Government’s website for clinical trials, www.clinicaltrials.gov. AAVantgarde reserves the right to revise this policy at any time, in accordance with the 21st Century Cures Act.