By Joseph Walker 

Gilead Sciences Inc. will stop considering individual emergency requests for its experimental coronavirus drug, except in certain circumstances, as it grapples with overwhelming demand, the company said Saturday.

Gilead and other researchers are conducting multiple clinical trials of the drug, remdesivir, in patients hospitalized by the virus. Initial study data will be available in the coming weeks, Gilead Chief Executive Daniel O'Day wrote in an open letter posted on the company's website.

Not all patients can get into the studies, either because they don't meet the clinical eligibility criteria or aren't being treated at a hospital participating in the trials. For severely ill patients who can't get into a study, doctors can make a "compassionate use" request for unapproved drugs, which have to be evaluated on a case-by-case 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," Mr. O'Day said in the letter, referring to the disease caused by the new coronavirus.

Gilead has provided remdesivir to more than 1,000 Covid-19 patients through its compassionate-use program, Mr. O'Day wrote. Going forward, however, Gilead will only consider individual requests for pregnant women and children. For all other patients, Gilead is setting up an "expanded access" program under which doctors and hospitals can apply for emergency use for multiple severely ill patients at a time.

Gilead said it would take time to set up a network of hospitals that can make the group requests, but initial sites in the U.S. were up and running as of Friday, and more sites in additional countries would be activated soon.

Write to Joseph Walker at joseph.walker@wsj.com

 

(END) Dow Jones Newswires

March 28, 2020 20:10 ET (00:10 GMT)

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