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US gives emergency-use authorization to Covid-19 treatment drug
The Food and Drug Administration, the regulator, said that though there is limited information available about the safety and effectiveness of the drug, it has been seen to shorten the recovery time in some patients.
The US drug regulator on Friday granted emergency use authorization for doctors to prescribe remdesivir, an antiviral medicine made by American pharmaceutical major Gilead Sciences Inc, for the treatment currently of hospitalized adults and children with severe coronavirus infection.
The Food and Drug Administration, the regulator, said that though there is limited information available about the safety and effectiveness of the drug, it has been seen to shorten the recovery time in some patients.
President Donald Trump announced with the emergency use authorization with a full-court briefing at the White House Friday accompanied by top officials of his coronavirus task force and the Gilead CEO Dan O’Day.
The president called the drug the “hot thing” and “an important treatment for hospitalized coronavirus patients” and a “promising situation”.
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The US drug regulator has said the emergency use authorization allows for remdesivir to be distributed in the US and administered intravenously by health care providers to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease, which it defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
The emergency use authorization was a much anticipated development after the president and the top US government epidemiologist declared positive outcome earlier in the week about form the clinical trial underway.
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“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Anthony Fauci, the top epidemiologist and member of President Donald Trump’s coronavirus task-force told reporters, prefacing the announcement as “quite good news”.
The trial, which was conducted by the National Institute of Allergy and Infectious Diseases that Fauci leads, showed “a drug can block the virus”, Fauci added and described it as “a new standard of care” for treating Covid-19.
He had gone on to compare development to the trial 36 years ago in 1986 that led to the HIV antiviral AZT, a drug that had then shown only “modest” efficacy but became the base for better and more improved treatments over the years.
Remdesivir is not a vaccine and cannot prevent Covid-19. It can treat Covid-19 better than any other drug around now
