USFDA allows emergency use of Gilead’s Remdesivir drug for Covid-19 patients

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The Emergency use of an investigational anti-viral vaccine to treat COVID-19 patients has been permitted by US food and drug regulatory body after research. It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide.
The Food and Drug Administration (FDA) gave emergency use authorisation (EUA) for the use of investigational anti-viral Remdesivir in the treatment of COVID-19 patients. The authorisation came after researches, including one led by Indian-American physician Aruna Subramanian, reported Remdesivir shortened the recovery times in people who have fallen ill from the new coronavirus.

The FDA decision was based on a review of top-line data from two clinical trials. In a placebo-controlled phase 3 trial conducted by the National Institute for Allergy and Infectious Diseases, 1,063 critically ill patients receiving remdesivir had an average recovery time of 11 days, compared with 15 days in the placebo group. Those receiving the drug also had a lower mortality rate, although the mortality result was not proven with statistical significance. Patients in Gilead’s own Simple-1 trial showed improvement as well, but that trial was for comparing two different durations of treatment and wasn’t placebo-controlled.

Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences said, “This EUA opens the way for us to provide emergency use of Remdesivir to more patients with severe symptoms of Covid-19. We will continue to work with partners across the globe to increase our supply of Remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile. We are working to meet the needs of patients, their families and healthcare workers around the world with the greatest sense of urgency and responsibility.”

“The EUA is based on available data from two global clinical trials the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s global Phase 3 study evaluating 5-day and 10-day dosing durations of Remdesivir in patients with severe disease”, according to Gilead.

Gilead is donating its entire current supply of the drug at no cost, which amounts to enough to treat 140,000 patients, assuming a course of treatment lasting 10 days. The biotech company is racing to ramp up manufacturing capacity and has set a goal of producing 500,000 treatment courses by October and a million by December. The Simple-1 study, though, suggested that a 5-day course of treatment produced similar results as a 10-day course, so Gilead now believes it will be able to treat far more patients than it thought when it set those goals.

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