Emergency Access to Remdesivir Outside of Clinical Trials
Enrollment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of this investigational medicine. Emergency treatment requests are considered only when enrollment in a clinical trial is not a feasible option.
Gilead is currently in the process of transitioning the provision of emergency access to remdesivir from individual compassionate use requests to expanded access programs. This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients. These programs are currently under rapid development in conjunction with national regulatory authorities worldwide.
Due to overwhelming demand over the last several days, during this transition period we are unable to accept new individual compassionate use requests, with the exception of requests for pregnant women and children less than 18 years of age with confirmed COVID-19 and severe manifestations of disease. We are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed.