Gilead is working to rapidly assess the safety and efficacy of Remdesivir as a potential treatment for COVID-19 through multiple ongoing 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.

We recognize that there are severely ill patients who are unable to enroll in clinical trials and for whom no approved treatment options are effective. Gilead has been working with regulatory agencies to provide Remdesivir to these patients where feasible. To date, we have provided emergency access to Remdesivir for several hundred patients in the United States, Europe, and Japan.

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In recent weeks, there has been an exponential increase in compassionate use requests for emergency access to Remdesivir, related to the spread of the Coronavirus in Europe and the United States. This has flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.

To streamline the emergency access process, Gilead is currently in the process of transitioning from individual compassionate use requests to expand 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 and may vary by region based on local laws and regulations.