Thursday | 16 January 2025 | Reg No- 06
Gilead Science Inc's antiviral drug remdesivir was granted emergency use authorisation by the US Food and Drug Administration for COVID-19 on Friday, clearing the way for broader use of the drug in more hospitals around the United States.
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.
Gilead said on Wednesday 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.
With many countries reeling 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.
"It's the first authorised therapy for COVID-19, so we're really proud to be part of it," FDA Commissioner Stephen Hahn said during the meeting.
Data released this week from a trial by the National Institutes of Health (NIH) in the United States showed that remdesivir reduced hospitalisation stays by 31% compared to a placebo treatment, but did not significantly improve survival.
Gilead did not immediately respond to a request for the price it plans to charge for the drug after its pledged donations are used up. 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.
- Reuters/QH
