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 During a meeting in the Oval Office of the White House with
President Donald Trump, Gilead Chief Executive Daniel O'Day called
the move an important first step and said the company was donating
1.5 million vials of the drug to help patients.
The donation is expected to be enough for at least 140,000 patients,
depending on the number of days they need to be treated.
Gilead said on Wednesday the drug, which is given by intravenous
infusion, had helped improve outcomes for patients with COVID-19,
the respiratory disease caused by the novel coronavirus, and
provided data suggesting it worked better when given earlier in the
course of infection.
With many countries reeling from the coronavirus pandemic, interest
in Gilead’s drug has been high because there are currently no
approved treatments or preventive vaccines for COVID-19. Doctors are
desperate for anything that might alter the course of the disease
that attacks the lungs and can shut down other organs in extremely
severe cases.
"It's the first authorized therapy for COVID-19, so we're really
proud to be part of it," FDA Commissioner Stephen Hahn said during
the meeting.
Data released this week from a trial by the National Institutes of
Health (NIH) in the United States showed that remdesivir reduced
hospitalization stays by 31% compared to a placebo treatment, but
did not significantly improve survival.
Gilead did not immediately respond to a request for the price it
plans to charge for the drug after its pledged donations are used
up. The Institute for Clinical and Economic Review, which assesses
effectiveness of drugs to determine appropriate prices, put the cost
of producing a 10-day course of remdesivir at $10, but suggested
that the price would rise to $4,500 based on patient benefits shown
in clinical trials.
Remdesivir was previously available only for patients enrolled in
clinical trials or for patients cleared to get the drug under
expanded use and compassionate use programs. Through Gilead's
trials, more than 181 hospital locations around the world, including
hospitals in 27 U.S. states, have been administering the drug.
The FDA authorization applies to patients hospitalized with severe
COVID-19 who require oxygen supplementation.
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U.S. Vice President Mike Pence said the 1.5 million vials would start being
distributed to hospitals on Monday.
Gilead said the federal government will coordinate the donation and distribution
of remdesivir to hospitals in cities hardest hit by COVID-19. Citing the drug's
limited supply, the company said hospitals with intensive care units and other
hospitals that the government deems most in need will receive priority.
There have been more than 3.2 million people infected by the novel coronavirus
worldwide and over 232,800 have died, according to a Reuters tally.
The United States has the most cases and fatalities at more than 1 million and
at least 63,200 with much of the country in lockdown to contain the spread of
the virus.
The recent clinical data has raised hopes remdesivir might be an effective
treatment.
A draft study abstract released inadvertently by the World Health Organization
(WHO) last week said remdesivir failed to improve patients’ condition or reduce
the pathogen’s presence in the bloodstream. The drugmaker said the findings were
inconclusive because the study was terminated early.
Remdesivir, which previously failed as a treatment for Ebola, is being tried
against COVID-19 because it is designed to disable the mechanism by which
certain viruses, including the new coronavirus, make copies of themselves and
potentially overwhelm their host's immune system.
Shares of Gilead, which have gained 26% so far this year, were up 2.7% at $82.10
in after hours trading.
GRAPHIC: Tracking the novel coronavirus in the U.S. https://tmsnrt.rs/2w7hX9T
(Reporting by Steve Holland; Additional reporting by Deena Beasley in Los
Angeles and Carl O'Donnell in New York; Writing by Jeff Mason; Editing by Grant
McCool and Daniel Wallis)
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