Gilead stops emergency access to experimental coronavirus drug
Gilead Sciences Inc announced it was temporarily putting new emergency access to its experimental coronavirus drug remdesivir on hold due to overwhelming demand, Reuters reports.
To prove it is safe and efective in the pandemic
The company wants most people receiving the drug to participate in a clinical trial to prove if it is safe and effective.
Remdesivir has been touted by many - including President Donald Trump - as one of the more promising potential treatments for the virus.
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.
New system - expanded access programs
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 inclinical trials
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.