Expanded Access Policy
At Adverum, our current focus is to rigorously investigate the clinical safety and effectiveness of our investigational gene therapy product, ixoberogene soroparvovec (Ixo-vec, formerly known as ADVM-022), an aflibercept-encoding viral vector for treating wet AMD. We believe that conducting our clinical studies effectively is the best path to potential regulatory approval and providing access to patients, who currently have access to several approved anti-VEGF agents for the treatment of
It is important to note that our investigational therapies have not yet received approval from the U.S. Food and Drug Administration (FDA) or other regulatory authorities. We have considered various factors consistent with the FDA’s guidelines and have decided not to provide unapproved therapies through expanded access (also referred to as compassionate use). We have determined that, at this time, participation in Adverum’s clinical studies is the most effective way for patients to access our investigational therapies before regulatory approval.
If you or a family member are/is interested in gaining access to our investigational therapy, we recommend consulting with your physician. Your physician can provide you with the necessary information and guidance regarding the possibility of participating in our clinical studies. For information about Adverum’s clinical studies Contact Us, or visit the US Government’s website for clinical trials, www.clinicaltrials.gov.
Please be aware that our posting of this policy does not guarantee access to any specific investigational therapy by any individual patient. In line with the 21st Century Cures Act, Adverum reserves the right to change this expanded access policy at any time.