Gilead transitioning to 'expanded access' program for experimental COVID-19 treatment

Gilead Sciences is transitioning to an "expanded access" program for its experimental COVID-19 treatment, remdesivir, because its current program can't support the "overwhelming" number of applications, Gilead CEO Daniel O'Day, wrote in an open letter published March 28.

Gilead has been testing remdesivir as a treatment for COVID-19 and Mr. O'Day said the drugmaker is on track to receive initial data from clinical trials in the "coming weeks."

Though the drug has yet to be FDA approved, Gilead has made it available for severely ill patients who can't enroll in a trial through a "compassionate use" program with patients and families of patients applying for use. Mr. O'Day said the drug has been given to more than 1,000 patients so far. 

However, the compassionate use program can't support and process the "overwhelming" number of applications seen with COVID-19, so the company is transitioning to an "expanded access" program, Mr. O'Day wrote. 

With the expanded access program, hospitals or physicians can apply for emergency use of remdesivir for multiple severely ill patients at a time. Mr. O'Day didn't offer more details on the program, but said this system should accelerate emergency access to remdesivir for more people. 

The compassionate use program will continue for children and pregnant women only. 

The expanded use program began March 27 at several sites in the U.S. and Gilead expects additional countries will join in the program soon, according to Mr. O'Day. 

Read the full letter here.

More articles on pharmacy:
Gilead asks FDA to take back orphan drug status for COVID-19 drug
Walmart nearly criminally charged over opioid prescriptions, report finds
13 drugmakers form consortium to find COVID-19 treatments

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