NEW YORK (Reuters) – Gilead Sciences Inc 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 outbreak. Some states have already taken steps to limit prescriptions of the drugs to those who need them most.
(Reporting by Michael Erman; Editing by Peter Cooney)
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