Gilead Limits Access to Experimental Coronavirus Drug Due to High Demand
March 28 2020 - 8:25PM
Dow Jones News
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)
Copyright (c) 2020 Dow Jones & Company, Inc.
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