Gilead Halts Access to Potential COVID-19 Drug Remdesivir

March 23, 2020 - Biopharmaceutical company Gilead announced that it will temporarily pause access to COVID-19 treatment, remdesivir, outside of clinical trials as demand becomes overwhelming. 

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Individuals who are currently receiving the experimental treatment will continue to have access for the time being, except for women who are pregnant and anyone under 18. 

“During this transition, we are unable to accept new individual compassionate use requests due to an overwhelming demand over the last several days,” Gilead said in the announcement. “We are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed.”

Remdesivir is an investigational broad-spectrum antiviral treatment developed by Gilead to treat Ebola back in 2013. It was also effective in treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). 

Due to previous success, experts believe that remdesivir may be an effective treatment for COVID-19. 

“We know the drug works against different coronavirus, like MERS and SARS, and we know the novel coronavirus is very similar to SARS. So I would say I’m curiously optimistic that the results our team found with remdesivir and MERS will be similar with COVID-19,” Matthias Gotte, a virologist, said in a recent statement. 

The New England Journal of Medicine recently highlighted that remdesivir was used on a patient earlier this year on the seventh day of COVID-19. The patient showed improvement the following day, and the symptoms eventually disappeared altogether. 

“What our study showed was that remdesivir essentially mimics one of the natural building blocks of RNA synthesis necessary for genome replication of the virus,” said Bruce Alyward, assistant director general of the World Health Organization. 

“Enzymes within the virus are synthesizing the RNA genome with these building blocks, but they mix up the bits they need with the drug. Once the drug is incorporated into the growing RNA chain, the virus can no longer replicate.” 

Gilead highlighted that there are currently five clinical trials in the US and China using remdesivir to treat COVID-19. And according to FDA, the drug has been used in 250 patients in the US outside clinical trials, also called compassionate use. 

Remdesivir was also recently supplied to Europe and Japan.

"We have had an exponential increase in compassionate use requests for emergency access to remdesivir that flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in the response to a pandemic," Gilead stated in the announcement. 

CDC listed other potential COVID-19 treatments, but none have been approved by the FDA so far. These treatments include hydroxychloroquine, a malaria treatment administered to hospitalized COVID-19 patients in multiple countries, including the US.

Hydroxychloroquine alone or in combination with azithromycin “reduced detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit," CDC said.

Despite these findings, CDC emphasized that there are currently “no available data from randomized controlled trials to inform clinical guidance on the use, dosing or duration of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection.”  

New York has been one of the states hit hardest with COVID-19. This past weekend, New York Governor Andrew Cuomo revealed that the Empire State had acquired 70,000 doses of hydroxychloroquine, 10,000 doses of Zithromax (azithromycin), and 750,000 doses of chloroquine to implement drug trials to start this week. 

“I want to thank the FDA for moving very expeditiously to get us this supply. The president ordered the FDA to move and the FDA moved,” Cuomo said. “The FDA should start approving serologic tests for coronavirus antibodies.”