The US drug regulator has allowed emergency use of experimental antiviral drug remdesivir for Covid-19 treatment based on early clinical data that showed it helps coronavirus patients recover faster. The drug is made by Gilead Sciences and is the first to be approved globally as a treatment for the viral pandemic that has killed over 240,000 people worldwide.
The emergency authorisation allows products to be used for treatment without full data on their safety and efficacy, which has to be still submitted as trials continue. “This was lightning speed in terms of getting something approved. From clinical trial to getting it authorised, it was 90 days,” said US Food and drug Administration (FDA) commissioner Stephen Hahn.
Remdesivir, when administered by an intravenous infusion, helped patients recover in 11 days on average , compared to 15 days taken by those on placebo, according to a study sponsored by the National Institute of Allergy and Infectious Diseases.
US President Donald Trump, who announced the authorisation at the White House on Friday accompanied by top officials of his coronavirus task force and Gilead CEO Dan O’Day, called the drug the “hot thing” and “an important treatment for hospitalised coronavirus patients” and a “promising situation”.
The emergency use will be limited to hospitalised Covid-19 patients with low blood-oxygen levels or those who need breathing support, the FDA said.
“It is reasonable to believe that remdesivir may be effective in treating Covid-19, and that, when used under the conditions described in this authorisation, the known and potential benefits of remdesivir when used to treat Covid-19 outweigh the known and potential risks of such products,” the US regulator said. “Remdesivir… will be used only to treat adults and children with suspected or laboratory confirmed Covid-19 and severe disease defined as SpO2 ≤ 94% on room air, requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).”
Hospitalised patients in need of oxygen support account for about 14% of Covid-19 patients, according to early studies of the outbreak. Patients on mechanical ventilator or ECMO should be given the drug for 10 days, while those who are less sick should get it for five days, Gilead said.
“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” said Anthony Fauci, a member of the White House coronavirus task force.
Former Indian Council of Medical Research director-general Dr Nirmal K Ganguly said Gilead plans to expand remdesivir trials to many countries, excluding India. “Since the supply (of remdesivir) is limited, according to Gilead, India must consider ways to make this drug available to its population,” said Ganguly.
Public Health Foundation of India president Dr K Srinath Reddy said one trial compared five days’ regimen with 10 days’ regimen and noted equal clinical recovery time. “There was no control group and effect on deaths was not studied. Another trial was randomised, had a control group of standard care, and observed a benefit in the reduction of recovery time from severe illness. The impact on death was, however, not statistically significant and hence unproven.’
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