Access To Astria’s Investigational Drugs Through Clinical Trials:
For an investigational drug to become approved by regulatory authorities, such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), it must first be rigorously and carefully researched. Essential to this research are clinical trials, in which the investigational drug is given to a pre-defined group of people with a specific condition or disease to evaluate the investigational drug for safety and effectiveness.
Currently, participation in Astria’s clinical trials is the only way to receive our investigational drugs.
Access to Astria’s Investigational Drugs Through Expanded Access Programs*:
Currently, Astria offers access to its investigational drugs only through our clinical trials. We regularly reevaluate our ability to support expanded access programs and will update this policy in the event there is a change in our ability to offer such programs.
*Expanded access (also called compassionate use or named patient use) permits patients who meet specific requirements made by a regulatory authority access to an investigational drug outside of participation in a clinical trial.
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