The United States Food and Drug Administration (USFDA) has granted emergency use authorisation (EUA) for the experimental drug Remdesivir to treat coronavirus patients.
“I’m pleased to announce that Gilead now has a EUA (emergency use authorisation) from the FDA for Remdesivir,” US President Donald Trump told reporters at the White House on Friday.
The US food and drug regulatory body allowed the drug’s authorisation after some studies, including one led by an Indian-American physician Aruna Subramanian, found that the drug Remdesivir shortened the recovery time for the hospitalised patients with severe coronavirus infection.
“Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that Remdesivir may be effective in treating Covid-19, and that, given there are no adequate, approved or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use,” FDA said in a statement.
A government-sponsored study earlier showed that the drug Remdesivir helped recover some of the infected coronavirus patients by 31%.
In a statement, Gilead Sciences said that the EUA will facilitate broader use of Remdesivir for the treatment of hospitalised patients with severe infection. The US-based vaccine maker added that the optimal duration of treatment is still being studied in ongoing clinical trials.
Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of the disease, Gilead Sciences noted.
The research-based biopharmaceutical company is working with the US government, USFDA and National Institute of Health on the logistics of distribution for the vaccine to enable its access across the country.
The authorization is temporary, Gilead said and added that Remdesivir remains an investigational drug, which has not been approved by the FDA.
The regulator body can revise the Remdesivir’s status from temporary to full approval if Gilead Sciences or other researchers generate more data on the safety and efficacy of the vaccine for treating coronavirus patients.
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