The U.S. Food and Drug Administration (FDA) has approved the use of remdesivir for the treatment of COVID-19 patients in hospitals. The experimental drug is manufactured by Gilead Sciences Inc. and is now approved for emergency coronavirus treatment in Japan. Gilead’s CEO Daniel O’Day said the company went from producing 5,000 courses of the drug per day to 100,000 and will have millions ready for use before the end of the year.
“We’re all focused on making sure we make this accessible and affordable to patients around the globe,” O’Day said. “That’s what’s going to drive us, and we take our responsibility very seriously.”
During clinical trials, coronavirus with severe cases of the disease were infused with remdesivir on a daily basis for 10 days. But Gilead said it is exploring better ways to administer the drug so that it can be more available to a wider population of patients. Its rate of speeding up recovery time in coronavirus patients was confirmed by the National Institutes of Health and other regulatory agencies.
With over one million infection cases in the US and at least 63,019 deaths according to Johns Hopkins University, President Donald Trump has endorsed the effectiveness of using remdesivir to treat COVID-19. NIAID’s director, Anthony S. Fauci, even said the medicine is now the “standard of care” for treating the infectious disease.
To determine the effectiveness of the experimental drug, the National Institute of Allergy and Infectious Diseases said remdesivir would be evaluated on the length of time it takes COVID-19 patients to recover, and not on the number of people that died or kept alive on ventilators. These latter factors would still be tracked, but the overriding performance factor would be how long it took patients to recover fully.
Given that the time it took patients to recover dropped from 15 days to 11 days with the use of remdesivir, Fauci said the reduced time marked a 31% improvement rate for the newly approved drug. “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” he said. “It’s highly significant.”
Fauci further admonished clinical trial researchers to stop further tests on patients placed on placebo so that they too could access the real drug since it is now proven to reduce hospitalization.
Source: bloomberg.com