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Gilead puts emergency access to experimental coronavirus drug on hold

Gilead Sciences said on Sunday it was temporarily putting new emergency access
to its experimental coronavirus drug remdesivir on hold due to
overwhelming demand and that it wanted most people receiving the
drug to participate in a clinical trial to prove if it is safe
and effective.

The drugmaker said in a statement there had been an
exponential increase in so-called compassionate-use requests for
the drug. The spread of the virus in Europe and the United
States has “flooded an emergency treatment access system that
was set up for very limited access to investigational medicines
and never intended for use in response to a pandemic,” it said.

Gilead said it would keep processing previously approved
requests.

Remdesivir has been touted by many – including President
Donald Trump – as one of the more promising potential treatments
for the virus.

The company said it was shifting from a system of individual
compassionate-use requests to expanded access programs, which it
expects will start in a similar time frame that new requests for
compassionate use would have been processed.

Gilead said it would make exceptions for pregnant women and
children under 18 with severe COVID-19, the highly contagious
respiratory disease caused by the coronavirus.

“Enrollment in clinical trials is the primary way to access
remdesivir to generate critical data that inform the appropriate
use of this investigational medicine,” Gilead said.

There are currently no approved treatments or preventive
vaccines for COVID-19. Researchers are studying existing
treatments and working on experimental ones, but most current
patients receive only supportive care such as breathing
assistance.

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Other potential treatments – like malaria drugs chloroquine
and hydroxychloroquine – are in short supply as demand has
surged with the rapid spread of the outbreak. Some states have
already taken steps to limit prescriptions of the drugs to those
who need them most.

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