Remdesivir granted emergency use approval by US for coronavirus patients: All you need to know
Remdesivir drug was originally developed to treat Ebola. It is an anti-viral and works by attacking an enzyme that a virus needs in order to replicate inside our cells.
Gilead Science Inc's anti-viral drug remdesivir has been granted emergency use authorization by the US Food and Drug Administration in the treatment of the novel coronavirus. The move clears the way for broader use of the drug in more hospitals around the United States.
Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the new coronavirus, make copies of themselves and potentially overwhelm their host’s immune system.
During a meeting in the Oval Office of the White House with President Donald Trump, Gilead Chief Executive Daniel O'Day called the move an important first step and said the company was donating 1.5 million vials of the drug to help patients.
The donation is expected to be enough for at least 140,000 patients, depending on the number of days they need to be treated.
"We're humbled by this being an important first step for ... hospitalized patients. We want to make sure nothing gets in the way of these patients getting the medicine, so we made a decision to donate about 1.5 million vials," he said.
Gilead said the drug, which is given by intravenous infusion, had helped improve outcomes for patients with COVID-19 -- the respiratory disease caused by the novel coronavirus -- and provided data suggesting it worked better when given earlier in the course of infection.
Gilead did not immediately respond to a request for the price it plans to charge for the drug after those donations are used up.
With many countries still struggling from the coronavirus pandemic, interest in Gilead’s drug has been high because there are currently no approved treatments or preventive vaccines for COVID-19. Doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.
The FDA authorization applies to patients hospitalized with severe COVID-19 who require oxygen supplementation.
Data released this week from a trial by the National Institutes of Health (NIH) in the United States showed that remdesivir reduced hospitalization stays by 31% compared to a placebo treatment, but did not significantly improve survival.
About 1,063 people took part in the trial. Some patients were given the drug while others received a placebo (dummy) treatment.
The Institute for Clinical and Economic Review, which assesses effectiveness of drugs to determine appropriate prices, put the cost of producing a 10-day course of remdesivir at $10, but suggested that the price would rise to $4,500 based on patient benefits shown in clinical trials.
Remdesivir was previously available only for patients enrolled in clinical trials or for patients cleared to get the drug under expanded use and compassionate use programs. Through Gilead's trials, more than 181 hospital locations around the world, including hospitals in 27 US states, have been administering the drug.
US Vice President Mike Pence said the 1.5 million vials would start being distributed to hospitals on Monday. Gilead said the federal government will coordinate the donation and distribution of remdesivir to hospitals in cities hardest hit by COVID-19. Citing the drug's limited supply, the company said hospitals with intensive care units and other hospitals that the government deems most in need will receive priority.
The novel coronavirus has so far killed more than 238,000 people and infected over 3.3 million worldwide. In the US, more than 1.1 million cases have been recorded with at least 65,000 deaths.
A draft study abstract released inadvertently by the World Health Organization (WHO) last week said remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. But the drugmaker said the findings were inconclusive because the study was terminated early.
Other drugs being investigated for COVID-19 include those for malaria and HIV which can attack the virus as well as compounds that can calm the immune system.
Prof Peter Horby, from the University of Oxford, is running the world's largest trial of Covid-19 drugs. He said: "We need to see the full results, but if confirmed this would be a fantastic result and great news for the fight against COVID-19.
"The next steps are to get the full data out and work on equitable access to remdesivir."