Gilead Expands Access To Investigational Anti-coronavirus Drug

Gilead Sciences Inc. said it is transitioning to “expanded access programs” from “compassionate use” programs for its experimental anti-coronavirus drug, remdesivir.

The company noted that the expanded access will allow hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at one time, as they struggle to deal with the COVID-19 or coronavirus pandemic.

“While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people. Initial sites in the United States are up and running as of yesterday, and it is expected that sites in additional countries will be activated soon,” said Daniel O’Day, Chairman and CEO of Gilead Sciences, in an open letter.

Gilead Sciences said that multiple clinical trials for the investigational drug’s effects in coronavirus patients are ongoing and it expects to have initial data from the trials in the coming weeks.

Under the compassionate use program, remdesivir was made available to more than 1,000 severely ill patients who cannot enroll in a trial. However, each application has to be reviewed on an individual basis under the program.

While this program works well when there is a limited number of requests, it cannot support and process the overwhelming number of applications seen with COVID-19, Gilead Sciences noted.

In February, Gilead Sciences had said remdesivir demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, coronaviruses that are structurally similar to 2019-nCoV – the new viral strain responsible for the current global pandemic.

In vitro is a procedure performed in a controlled environment outside of a living organism. In vivo studies are conducted inside living organisms.

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