Gilead Revamps Process for Emergency Requests for Experimental Coronavirus Drug -- Update
March 28 2020 - 9:42PM
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.
The move is part of the drugmaker's overhaul of the process for
doctors requesting emergency use of the experimental drug
remdesivir outside of clinical trials. Gilead said it is making the
changes because it can't handle all the requests it is getting, and
hoping the revamping will eventually speed up the process and
expand access to more patients.
Gilead and other researchers are conducting multiple clinical
trials of 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 21:27 ET (01:27 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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