FDA Authorizes Emergency Use of Remdesivir
The use of Gilead’s Remdesivir broadens in more hospitals around the United States as on Friday, the FDA granted emergency use authorization for Gilead Science Inc’s (GILD.O) antiviral drug remdesivir for Covid-19.
Daniel O’Day, Gilead Chief Executive said that to help the Covid-19 patients, the company was donating 1.5 million vials of the drug. Depending on the number of days the patients need to be treated, this donation is expected to be sufficient for at least 140,000 patients.
Gilead provided data suggesting that the drug, given by intravenous infusion, worked better when given earlier in the course of infection and has helped improve outcomes for Covid-19 patients.
As there are no approved preventive vaccines or treatments for Covid-19, the interest in Gilead’s drug has been high.
During the meeting, Stephen Hahn, the FDA Commissioner said, “We are really proud to be part of this as it is the first authorized therapy for COVID-19 patients.”
It was seen that 31% of hospitalization stays compared to a placebo treatment was reduced by using remdesivir but did not significantly improve survival, according to the data released from a trial by the National Institutes of Health (NIH) in
the United States.There has not been any immediate response from Gilead regarding the price it plans to charge for the drug after using up its pledged donations. The cost of producing a 10-day course of remdesivir was put at $10 by the Institute for Clinical and Economic Review (assesses the effectiveness of drugs to determine appropriate prices), but also suggested that based on patient benefits shown in clinical trials, the price would rise to $4,500.
Previously, only for patients cleared to get the drug under expanded use and compassionate use programs or for patients enrolled in clinical trials could use Remdesivir. Now the drug has been administered by more than 181 hospital locations around the world, including hospitals in 27 U.S. states, through Gilead’s trials.
The FDA authorization applies to patients who require oxygen supplementation having severe COVID-19.
Hospitals will be distributed with the 1.5 million vials, starting from Monday, said the U.S. Vice President Mike Pence.
To the hospitals in cities hardest hit by COVID-19, the federal government will coordinate the donation and distribution of remdesivir, said the company. The company added that hospitals with intensive care units and other hospitals that the government deems most in need will receive priority given the drug’s limited supply.
The United States has much of the country in lockdown to contain the spread of the virus has it has the most cases and fatalities from the COVID-19 infection.
Hopes of remdesivir being an effective treatment for COVID-19 is raised with recent clinical data. Certain viruses, including the novel coronavirus causing COVID-19, potentially overwhelm their host’s immune system by make copies of themselves. Remdesivir is being tried against COVID-19 because it is designed to disable this mechanism.
So far this year, Gilead’s shares have gained 26%, went up 2.7% at $82.10 in after-hours trading.
Source
FDA Authorizes Emergency Use of Remdesivir
