FDA Nears Decision Authorizing Covid-19 Treatment With Convalescent Plasma -- Update
July 29 2020 - 5:33PM
Dow Jones News
By Amy Dockser Marcus and Thomas M. Burton
The Food and Drug Administration is nearing a decision to
authorize emergency use of antibody-rich blood plasma from
recovered Covid-19 patients for treating people infected with the
coronavirus, people familiar with the matter said.
The authorization could come as early as next week, according to
the people, though the agency could also decide to delay a
decision.
The designation could open the way for faster and wider access
to one of the most promising treatments for Covid-19 patients. Only
a Gilead Sciences Inc. antiviral drug known as remdesivir carries
the designation.
The FDA can authorize a drug's use in an emergency such as a
pandemic after finding the treatment is safe and there is evidence
of probable benefit. The designation might also prompt federal
health officials to approve payment for the treatment under
Medicare and Medicaid.
The FDA didn't immediately respond to a request for comment.
There is a long history of using convalescent plasma to treat
people during past outbreaks, including Ebola and influenza.
Because of a lack of proven drugs, some doctors and hospitals
have been treating hospitalized Covid-19 patients with convalescent
plasma under compassionate use and as part of studies.
More than 48,000 Covid-19 patients have received convalescent
plasma through an expanded-access program sponsored by the FDA and
led by the Mayo Clinic in Rochester, Minn., which is also studying
whether the treatment works safely.
Michael Joyner of the Mayo Clinic, the principal investigator of
the expanded-access study, said in an interview earlier this month
that hospitals in virus hot spots giving convalescent plasma are
struggling to treat patients while filing case reports and keeping
up with data reporting.
An FDA emergency-use authorization could cut red tape for the
hospitals and allow faster access to the therapy.
Preliminary studies have found convalescent plasma is generally
safe to use and appears to improve the survival of hospitalized
patients.
Researchers are also exploring whether earlier use of
convalescent plasma could reduce the severity of illness and cut
the number of hospitalizations.
This week researchers at the University of Pittsburgh, Michigan
Medicine, Medical University of South Carolina and Stanford
Medicine said they received federal funding for a 600-subject study
that will in part look at such earlier use in patients starting to
show symptoms.
As part of the trial, Covid-19 patients who showed up at a
hospital with milder cases will be sent home after receiving either
convalescent plasma or saline, then monitored to see whether the
plasma prevented people from getting sicker or needing to return to
the hospital.
If the plasma's outpatient use proves effective, "We may rely on
this while we wait for a vaccine," said Clifton Callaway, executive
vice chair of emergency medicine at the University of Pittsburgh
and one of the principal investigators on the trial.
William Hartman, a doctor at the University of Wisconsin,
Madison, who is treating hospitalized Covid-19 patients with
convalescent plasma, said FDA emergency-use authorization may
prompt more hospitals to give the treatment earlier.
"I think the data are pretty clear that using it as early as
possible has advantages, and we should explore that possibility,"
he said.
Dr. Hartman and colleagues studied 31 severely ill Covid-19
patients who were hospitalized and received convalescent plasma as
part of the expanded access study.
The study's results, which were posted on a public server but
haven't yet undergone peer review, indicated that most of the
transfused patients with severe disease didn't have to go to the
intensive-care unit or receive mechanical ventilation.
Write to Amy Dockser Marcus at amy.marcus@wsj.com and Thomas M.
Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
July 29, 2020 17:18 ET (21:18 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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