AviadoBio Policy on Expanded Access to Investigational Therapies
At AviadoBio, we are extremely sympathetic to patients and families seeking care for loved ones diagnosed with debilitating neurological disorders. Our mission is to develop and deliver potentially transformative gene therapies for people living with neurodegenerative diseases such as frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). Our team is working relentlessly to overcome the challenges of delivering the right drug to the right place in the CNS. Our innovative approach is designed to maximize the therapeutic potential of gene therapy to halt or potentially reverse neurodegenerative diseases.
Our Commitment to Clinical Research
We are committed to working closely with researchers, doctors, clinical trial site teams, patients and families to enroll, conduct and analyze our clinical studies. If successful, data from these studies may support submissions to regulatory authorities (such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)) for approval – with the ultimate goal of making our medicines available to as many eligible patients in need as safely and quickly as possible.
Expanded Access/Compassionate Use Policy
At this time, AVB-101 is an investigational gene therapy that is only available to participants in ongoing clinical trials. More information on the ongoing ASPIRE-FTD study can be found here.
There is currently no ‘expanded access program’ for AVB-101. Expanded access is sometimes also referred to as compassionate use or pre-approval access, which is sometimes offered by companies, typically at a later stage of drug development when there are more data available on the investigational product.
If you have any questions about this expanded access policy, please ask your doctor to contact us at expandedaccess@aviadobio.com. We will acknowledge receipt of expanded access questions or requests sent to us within five (5) business days of receipt.
We will continue to evaluate the possibility of expanded access as we advance development of our investigational medicines. AviadoBio may revise this Expanded Access Policy at any time in keeping with the 21st Century Cures Act.
