The New York Times :
The Food and Drug Administration said on Thursday that it had formally approved remdesivir as the first drug to treat Covid-19, a move that indicated the government’s confidence in its safe and effective use for hospitalized patients.
The FDA said the drug had been approved for adults and pediatric patients ages 12 and older and weighing at least 40 kilograms (about 88 pounds) who require hospitalization for Covid-19, the disease caused by the coronavirus, which has killed more than 220,000 people in the United States.
The FDA had granted remdesivir emergency authorization in May after a trial by the National Institutes of Health found that it modestly reduced the recovery time in hospitalized patients. President Donald Trump received the antiviral drug after he began showing symptoms earlier this month. The drug does not prevent death from Covid-19.
The formal approval by the FDA indicated that the drug had cleared more rigorous regulatory hurdles involving a more thorough review of clinical data and manufacturing quality since it was given emergency authorization in May.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” Dr Stephen Hahn, the agency’s commissioner, said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.”
Remdesivir, which was originally developed as a treatment for Ebola and hepatitis C, interferes with the reproduction of viruses by jamming itself into new viral genes. A study of more than 11,000 people in 30 countries sponsored by the World Health Organization found that the drug failed to prevent deaths in patients with Covid-19.
The drug did not go through an outside panel of experts, called an advisory committee, before being approved.
The Food and Drug Administration said on Thursday that it had formally approved remdesivir as the first drug to treat Covid-19, a move that indicated the government’s confidence in its safe and effective use for hospitalized patients.
The FDA said the drug had been approved for adults and pediatric patients ages 12 and older and weighing at least 40 kilograms (about 88 pounds) who require hospitalization for Covid-19, the disease caused by the coronavirus, which has killed more than 220,000 people in the United States.
The FDA had granted remdesivir emergency authorization in May after a trial by the National Institutes of Health found that it modestly reduced the recovery time in hospitalized patients. President Donald Trump received the antiviral drug after he began showing symptoms earlier this month. The drug does not prevent death from Covid-19.
The formal approval by the FDA indicated that the drug had cleared more rigorous regulatory hurdles involving a more thorough review of clinical data and manufacturing quality since it was given emergency authorization in May.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” Dr Stephen Hahn, the agency’s commissioner, said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.”
Remdesivir, which was originally developed as a treatment for Ebola and hepatitis C, interferes with the reproduction of viruses by jamming itself into new viral genes. A study of more than 11,000 people in 30 countries sponsored by the World Health Organization found that the drug failed to prevent deaths in patients with Covid-19.
The drug did not go through an outside panel of experts, called an advisory committee, before being approved.
