- Illness or condition must be serious or immediately life-threatening
- No comparable or satisfactory alternative therapy is available
- Potential benefit justifies the potential risks of the treatment, and those risks are not unreasonable in the context of the disease or condition being treated
- Providing access to the investigational medicine will not interfere with or compromise clinical development
Avidity is focused on enrolling and conducting the clinical trials that are needed to bring AOCs to patients as quickly as possible through the regulatory approval process. We support expanded access programs when we have substantial scientific evidence to support both the safety and the efficacy of an investigational therapy. At this time, Avidity does not have an investigational therapy available for expanded access. We will continue to assess this as our clinical programs progress. We believe that wherever possible, participation in a clinical trial is the best and preferred route to access our investigational medicines. Clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. For a list of Avidity sponsored clinical trials currently recruiting patients, please visit www.clinicaltrials.gov.
Treating physicians may request information about Avidity’s Expanded Access policy by contacting our team at MedInfo@aviditybio.com.
Avidity conducts regular review of its policies to ensure conformity with applicable laws and regulations. Consistent with the 21st Century Cures Act, we reserve the right to revise this policy at any time.