- US health regulators are planning to authorise the emergency use of an experimental coronavirus treatment as soon as today, the New York Times reported.
- The US Food and Drug Administration is currently planning the announcement, the NYT reported, citing a senior administration official.
- In a statement to Business Insider, FDA didn’t say whether it would allow emergency use of the drug.
- Study results released Wednesday showed hospitalized COVID-19 patients recovered 31% faster when taking the antiviral drug remdesivir compared to a placebo group.
- The move would broaden the 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.
- The agency previously authorised the emergency use of the malaria pills chloroquine and hydroxychloroquine to treat coronavirus.
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The US Food and Drug Administration is planning to allow emergency use of a leading coronavirus treatment candidate,The New York Times reported Wednesday.
The emergency use authorization could come as soon as today, the report said, citing a senior administration official who wasn’t identified. The regulatory action would quickly follow positive trial results showing the medicine helped patients recover 31% faster than a placebo group.
The drug, called remdesivir, is made by the biotech Gilead Sciences. Wednesday featured a deluge of new developments concerning the drug, including seemingly contradictory study results.
In a statement to Business Insider, FDA didn’t say whether it would allow emergency use of the drug.
“The agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate,” an FDA spokesperson said.
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.
For emergency use, regulators have to decide if a drug is “likely to be more helpful than harmful for emergency use,” according to the agency.
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.
It’s unclear what type of restrictions the agency would put on the emergency use of remdesivir. It has only been studied in hospitalized patients and is given as an IV infusion.
The National Institutes of Health released preliminary results after testing more than 1,000 hospitalized COVID-19 patients with either remdesivir or a placebo. Researchers found Gilead’s drug led to a 31% faster recovery time when compared to placebo.
Eight per cent of patients taking remdesivir died compared to 11.6% of those on placebo, though the difference wasn’t statistically significant.
A separate trial in China did not find a meaningful benefit for remdesivir compared with a placebo, according to results published Wednesday in The Lancet, a top medical journal.
That study was stopped early because of difficulty in finding enough COVID-19 patients to enroll in China, the researchers noted. Given that that study didn’t reach full enrollment, the results are “inconclusive,” John David Norrie, a professor at the University of Edinburgh, said in an accompanying commentary.
Also on Wednesday, Gilead released data from its own trial. This study did not have a placebo group, which makes results difficult to interpret. Gilead executives said the study generated similar results in patients given either a five- or 10-day treatment course of the drug.