SAN FRANCISCO – An experimental and unproven coronavirus treatment so popular new requests to use it were halted a week ago due to "overwhelming" demand is once again available to doctors under an expanded access program.
President Donald Trump called the drug, remdesivir, “promising” 10 days ago, though there is no data yet to show whether it is safe and effective at treating COVID-19. It was originally created as a potential treatment for the Ebola and Marburg viruses.
On Saturday, Gilead Sciences CEO Daniel O’Day announced in an open letter that his company was once again making remdesivir available outside of the six ongoing clinical trials investigating whether it is effective as a treatment for COVID-19
Distribution of the drug will be under a government-approved "expanded access" program.
No data from those trials is yet available that would tell doctors whether the drug helps COVID-19 patients.
O’Day said Gilead, based in Foster City, California, hoped to have at least initial data on whether it works “in the coming weeks.”
“We are doing this before knowing whether the drug is safe and effective to treat COVID-19 because of the urgency of the situation,” a company spokeswoman said via email.
Remdesivir can only be administered by intravenous infusion over the course of between 30 and 120 minutes. It is not available as a pill or a shot.
Trump touted the drug, which has never been approved for general use, in a news conference on March 19.
At the time it was only being distributed under "compassionate use" rules requiring each application to be reviewed individually. Typically such programs are reserved for a small number of cases.
So many doctors asked for access to the drug that demand overwhelmed the company. On March 22 Gilead halted review of new individual requests for emergency access to remdesivir outside of clinical trials, except for pregnant women and children.
The system could not "support and process the overwhelming number of applications we have seen with COVID-19," O'Day wrote.
To expedite access, the company announced Saturday it had begun transitioning to a system using an "expanded access" program. This allows hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time.
The initial expanded access sites include two in New York, one in New Jersey and one in Louisiana, the company said Saturday, with more expected to be added.
Pregnant women and children will still have to go through the compassionate use program due to the very limited data available on the drug’s use in those populations, the company said. That will allow it to make a thorough assessment of the benefits and risks and collected follow-up safety data.
In addition to these two programs, there are six ongoing clinical trials of remdesivir as a treatment for COVID-19 internationally.
Two began in China in early February, one for patients with severe disease and one for those with mild to moderate disease. The U.S. National Institutes of Health launched a trial in February to test it on people hospitalized with evidence of lung involvement. The National Institute of Health and Medical Research in France, in conjunction with the World Health Organization, is testing the drug.
Gilead also launched two studies of its own this month, one in patients with severe disease and the other in patients with moderate disease.
The company came under fire last week when it asked for, and was granted, orphan drug status for remdesivir. The status is meant for drugs used for rare diseases and gives drugmakers tax breaks, Food and Drug Administration fee waivers and a seven-year window before other companies can begin to sell generic versions.
There was such an outcry against what many called profiteering that Gilead made the rare decision to ask the FDA to rescind the status.
Fact check: Drugmaker Gilead Sciences claimed rights to a possible COVID-19 treatment