Gilead puts emergency access to experimental coronavirus drug on hold

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.

Other potential treatments – like malaria drugs chloroquine


and hydroxychloroquine – are in short supply as demand has


surged with the rapid spread of the outbre

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