First doses of Gilead’s COVID-19 drug remdesivir to arrive at US hospitals
The first doses of Gilead’s COVID-19 drug remdesivir are set to arrive in US hospitals this week after the FDA said the medicine can be used to fight the coronavirus pandemic.
Although remdesivir is yet to be formally reviewed by the FDA, the regulator said that top-line results from phase 3 trials were compelling enough to grant an Emergency Use Authorization (EUA) to fight the COVID-19 pandemic.
The FDA referred to the phase 3 data published by the US National Institute for Allergy and Infectious Disease (NIAID) last week showing that remdesivir helps reduce recovery time in patients hospitalised with serious COVID-19 symptoms.
Median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo, and there was a non-significant trend suggesting a survival benefit.
The FDA also referred to data from Gilead’s phase 3 trial showing that a five-day treatment regimen produced similar effects to a 10-day treatment regimen in seriously ill patients – an important development as it increases the number of patients who could receive the drug.
Under the EUA the US government will be in charge of distributing remdesivir to hospitals and clinics across the country.
Gilead has donated its entire supply of 1.5 million vials of the injected drug to the US government.
Gilead’s CEO Daniel O’Day told CBS News’ Face The Nation programme: “We are now firmly focused on getting this medicine to the most urgent patients around the country here in the United States.
“We intend to get that to patients in the early part of this next week, beginning to work with the government, which will determine which cities are most vulnerable and where the patients are that need this medicine.”
Former FDA commissioner Scott Gottlieb, who also appeared on the show, added: “Remdesivir is an effective drug. It’s going to help some patients, especially when used early in the course of disease, to reduce hospitalisations, and reduce death.”
Remdesivir is a nucleoside ribonucleic acid (RNA) polymerase inhibitor, which works by interfering with the action of an enzyme involved with viral reproduction.
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