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 The U.S. Food and Drug Administration on Friday gave emergency use
authorization to Gilead Sciences Inc's remdesivir for patients with
severe COVID-19 - the disease caused by the coronavirus - clearing
the way for broader use in more hospitals around the United States.
The federal government began distributing the drug this week. But
doctors across the country, particularly in COVID-19 hotspots like
New York and Boston, became concerned after being denied their
request to obtain the new therapy, IDSA president Dr. Thomas File
told Reuters on Thursday.
"Some are seeing other hospitals approved, but say 'we have more
cases than they do, so why were we turned down?'" he said.
The IDSA on Wednesday called on the Trump Administration to explain
how it will ensure equitable distribution of remdesivir to states
and hospitals based on COVID-19 case and hospitalization rates.
The physician group also stressed the importance of fair allocation
to health facilities in communities disproportionately affected by
the coronavirus, including African American and Hispanic
populations.
The IDSA said it did not know how many hospitals had so far been
authorized to receive remdesivir or how many had been turned down.
Gilead last week donated 1.5 million vials of the drug to U.S.
hospitals, enough to treat at least 140,000 patients.
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The Federal Emergency Management Agency (FEMA) and the Department of Health and
Human Services (HHS) are coordinating the donation and distribution of
remdesivir.
Hospitals with intensive care units "and other hospitals that the government
deems most in need will receive priority," Gilead said in an emailed statement.
Officials at FEMA and HHS did not immediately respond to requests for comment.
AmerisourceBergen Corp, the exclusive distributor for the drug, said decisions
on which hospitals and the quantity of product they will receive are being made
by the government.
Gilead's donation "is likely to fall short of demand" for the drug throughout
the summer, the IDSA said.
In a large clinical trial released last week, remdesivir was shown to speed
recovery times of hospitalized COVID-19 patients compared to a placebo.
Gilead announced on Thursday that the drug has been approved for use in Japan.
"We are working out the details of the allocation to Japan and do not have
specifics to share at this time," the company said in an email.
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