Expanded Access Policy
At Aeglea, we are committed to patient health, safety and well-being. We focus our research and development on diseases where we can make a difference in the lives of patients who have few or no effective therapeutic options. As part of the drug development process, we work closely with patients to help us better understand how disease affects their everyday lives, which enables us to find creative solutions for bringing potentially life-changing treatments to patients faster. We are committed to developing potential new therapies and making them available to patients around the world through a variety of mechanisms allowed by regulatory authorities and we work with a sense of urgency to deliver these therapies through the approval process to make them more widely available. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.
Aeglea is creating and developing safe and effective medicines to treat serious diseases with high unmet medical need. Clinical trials are required to establish whether an investigational medical product is safe and effective, and participants in clinical trials play an important role in helping to improve the understanding and treatment of serious diseases. At present we believe that participation in one of our clinical trials is the most appropriate way to access our investigational therapies and we are not currently providing investigational drugs for expanded access.
Clinical Study Information
To participate in a clinical study, one must meet certain eligibility criteria. These criteria are designed to allow researchers to better evaluate the investigational therapy. If applicable, you should discuss participation in a clinical study with your physician who knows your medical history and current status and can discuss if you may be able to join a clinical study.
For information on ongoing clinical studies visit ClinicalTrials.gov or for Aeglea ongoing clinical studies click here or contact the Aeglea Patient Engagement team at firstname.lastname@example.org.
If you locate a clinical study and a participating site that you are interested in, you or your physician may contact that site directly for more information.
If you have questions, please speak with your physician or contact Aeglea at email@example.com. As our clinical programs progress, we may periodically revise our position on expanded access based on changes to regulations and the emergence of new scientific evidence.