Gilead puts emergency access to remdesivir on hold

Gilead puts emergency access to remdesivir on hold

Gilead Sciences Inc said it was temporarily putting new emergency access to its experimental coronavirus drug remdesivir on hold due to overwhelming demand.

The company wants most people receiving the drug to participate in a clinical trial to prove if it is safe and effective.

“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 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 considered as one of the potential treatments for the virus.

The company said it was shifting from a system of individual compassionate-use requests to expanded access programmes, 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.

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