- The US Food and Drug Administration will allow emergency use of Gilead’s coronavirus treatment remdesivir.
- Remdesivir helped coronavirus patients recover 31% faster than those taking a placebo, the US National Institutes of Health said Wednesday.
- The move allows for broader use of remdesivir. However an emergency use authorization is not regulatory approval. The FDA can apply a lower standard of evidence to allow emergency use.
- FDA is only allowing the use of remdesivir in relatively sick coronavirus patients who are hospitalized.
The US Food and Drug Administration is allowing emergency use of Gilead Sciences’ new coronavirus treatment.
The regulatory action quickly follows positive trial results showing the drug, called remdesivir, helped coronavirus patients recover 31% faster than a group that got a placebo. Remdesivir has only been studied in hospitalized patients and is given as an IV infusion, so it’s unlikely to become a broadly used treatment.
An emergency use authorization is not the same as a typical approval. Emergency use is only allowed during public health emergencies, and treatments face a lower bar of evidence than used for FDA approval. There are no drugs that are specifically approved to treat COVID-19, the disease caused by the coronavirus.
“It is reasonable to believe that remdesivir may be effective in treating COVID-19,” FDA said in a letter authorizing the drug’s emergency use. “When used under the conditions described in this authorization, the known and potential benefits of remdesivir when used to treat COVID-19 outweigh the known and potential risks of such products.”
The agency previously allowed the emergency use of chloroquine and hydroxychloroquine, the anti-malaria pills. It also stipulated these drugs were only to be used when a patient was hospitalized and could not enroll in a suitable clinical trial.
FDA is only allowing for the use of remdesivir in relatively sick coronavirus patients who are hospitalized. To be eligible for the drug, patients need to have severe symptoms of the disease, such as a need for oxygen or other help breathing.
The US government will handle distribution of the drug, and Gilead said supplies will go to hospitals in cities that have been hit hardest by the coronavirus. The company has said it will donate its existing supplies of the drug, which are enough for about 140,000 treatment courses. Gilead hasn’t revealed how it will set the treatment’s price in the future.