Pre-Approval Access Statement
Pre-approval access, also known as ‘expanded access’, ‘compassionate use’, ‘early access’ or ‘managed access’ provides a potential pathway for patients with serious disease or immediately life-threatening disease or condition to gain access to an investigational product for treatment outside of clinical trials when no comparable or satisfactory alternative options are available.1
At this time, Encoded’s gene therapies are investigational, which means that they have not been approved as safe and effective by regulatory health authorities (e.g. United States Food and Drug Administration, FDA). It is important to note that providing early access to an investigational therapy can involve unknown risks, as well as an unfounded assumption of therapeutic benefit. Furthermore, pre-approval access may make it harder to complete the studies necessary for the regulatory review and approval that is ultimately the fastest path to making new therapies available to as many patients as possible.
Encoded is collaborating closely with multiple regulatory authorities, the patient community, and medical experts to design and conduct safe and rigorous clinical trials. We believe that participation in well-designed clinical trials is the most ethical and expeditious way to determine the safety and efficacy of investigational therapies, and provides the highest probability of successfully bringing an approved gene therapy to the entire patient community in the safest manner. As such, Encoded does not currently offer pre-approval access anywhere in the world.
If you are a patient seeking more information on participating in Encoded’s clinical trials, please contact our Patient Advocacy team at email@example.com.
If you are a healthcare professional seeking more information on Encoded’s development programs, please contact our Medical Information team at firstname.lastname@example.org.
1 U.S. Food & Drug Administration. (2022, November). Expanded Access | Information for Patients. fda.gov