A recent clinical trial showed the drug helped shorten the recovery time for people who were seriously ill.The authorisation means the anti-viral drug can now be used on people who are hospitalised with severe Covid-19.
However, it did not significantly improve survival rates.Experts have warned the drug – which was originally developed to treat Ebola, and is produced by Gilead pharmaceutical company in California – should not be seen as a “magic bullet” for coronavirus.
The drug interferes with the virus’s genome, disrupting its ability to replicate.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.”
Emergency FDA authorisation is not the same as formal approval, which requires a higher level of review.The drug did not cure Ebola, and Gilead says on its website: “Remdesivir is an experimental medicine that does not have established safety or efficacy for the treatment of any condition.” Gilead also warns of possible serious side-effects.
However, President Trump has been a vocal supporter of remdesivir as a potential treatment for the coronavirus. In its 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 – including the US, France, Italy, the UK, China and South Korea. Some patients were given the drug and others were given a placebo (dummy) 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 having to be treated in intensive care – the trials did not give any clear indication whether it can prevent deaths from coronavirus.
As much remains uncertain about the treatment regime, Gilead suggests a 10-day dosing duration for patients on ventilators and five days for patients who are not.
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