Gilead switches to expanded access program for remdesivir

March 29, 2020

Gilead Science will switch from a “compassionate use” program to “expanded access” in order to accelerate emergency use of its experimental drug remdesivir for multiple severely ill patients.

The drugmaker said it is expecting to have initial remdesivir drug data in coming weeks. The experimental drug was developed to combat infectious diseases such Ebola and SARS, but was found ineffective. It is currently being evaluated as a potential treatment for coronavirus patients.

In the meantime, Gilead has made the investigational medicine available for severely ill patients who cannot enroll in a trial, through a compassionate use program. But according to Daniel O’Day, Gilead CEO, "The program is designed by regulatory authorities in such a way that each application has to be reviewed on an individual basis. This works well when there is only a limited number of requests – as is normally the case – but the system cannot support and process the overwhelming number of applications we have seen with COVID-19."

To address this, Gilead is transitioning to what should be a more streamlined, sustainable approach with expanded access programs. With expanded access, hospitals or physicians can apply for emergency use of remdesivir for multiple severely ill patients at a time.

The compassionate use program will continue for children and pregnant women only, reducing the numbers to a level where the system can cope.

Read the letter from Daniel O-Day