WASHINGTON: The United States Food and Drug Administration (FDA) has authorised the emergency use of the Ebola drug remdesivir for treating the coronavirus.
The authorisation means the anti-viral drug can now be used on people who are hospitalised with severe COVID-19. A recent clinical trial showed the drug helped shorten the recovery time for people who were seriously ill.
The emergency FDA authorisation is not the same as formal approval, which requires a higher level of review. The drug was originally developed to treat Ebola and is produced by Gilead pharmaceutical company. Experts have warned the drug should not be seen as a “magic bullet” for coronavirus. treatment.
During a meeting with US President Donald Trump in the Oval Office, Gilead Chief Executive Daniel O’Day said the FDA authorisation was an important first step. The company would donate 1.5 million vials of the drug, he said.
FDA Commissioner Stephen Hahn also said at the meeting: “It’s the first authorised therapy for Covid-19, so we’re really proud to be part of it.” President Trump has been a vocal supporter of remdesivir as a potential treatment for the coronavirus.
During a clinical trial, the US National Institute of Allergy and Infectious Diseases (NIAID) found that remdesivir cut the duration of symptoms from 15 days down to 11. The trials involved 1,063 people at hospitals around the world. Some were given the drug and others were given placebo treatment.
Dr Anthony Fauci who runs NIAID, said that remdesivir had “a clear-cut, significant, positive effect in diminishing the time to recovery”. However, although remdesivir may aid recovery and possibly stop people from having to be treated in intensive care, the trials did not give any clear indication whether it can prevent deaths from coronavirus.
Gilead’s investigational antiviral for the treatment of COVID-19 receives @US_FDA Emergency Use Authorization. This more readily enables treatment of hospitalized patients with severe COVID-19 disease in the United States. Read more: https://t.co/p4LR0RM7sI. pic.twitter.com/4kg9oDQPRq
— Gilead Sciences (@GileadSciences) May 1, 2020