India approves emergency use of remdesivir to treat COVID-19 patients


Gilead Sciences Inc is developing easier-to-administer versions of its antiviral treatment remdesivir for COVID-19 that could be used outside of hospitals, including ones that can be inhaled, after trials showed moderate effectiveness for the drug given by infusion. While Gilead stated that this was done to protect patients from the drug's unknown side effects, physicians argue that excluding the sickest patients from clinical trials bias the data. The median number of days to recovery had shortened from 15 days to 11 days.

The results announced by Gilead on Monday are from a study created to evaluate the safety and efficacy of 5- and 10-day treatment with remdesivir in addition to standard of care for patients with moderate Covid-19, compared with standard care alone. Only adults and children who are suspected or have laboratory-confirmed cases and show signs of a sever COVID-19 infection will be given this drug for a period of five days. A study from the New England Journal of Medicine found that 68% of Covid19 patients who received the drug showed an improvement, and 57% were able to come off ventilators. Given the alarming levels of spread and severity, some approved drugs are being tested to see if they are effective in treating infected patients. The 10-day course did not show improvements that were statistically significant compared to standard care, but Gilead says the odds of improvement were favorable, "trending towards" significance. A second phase of the study added up to 1,000 additional patients with moderate manifestations, and the results will be available in the coming months. Nausea and headache were a little more common among those on the drug.

COVID-19 has no approved treatment or vaccine yet.

The ministry said it will cooperate with Gilead, the Korea Centers for Disease Control and Prevention and other ministries to swiftly import the drug.

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The US Food and Drug Administration cleared remdesivir under an emergency authorization on May 1, which has allowed hospitalized patients with severe cases of COVID-19 to begin using the therapy.

"The drug, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in hospital or institutional set-up only".

Speaking on which, Francisco Marty, MD, Associate Professor of Medicine at Harvard Medical School said that these clinical outcomes offer supplementary encouraging data for remdesivir, indicating that a 5-day treatment course in early stages of COVID-19 can considerably improve the clinical outcomes for these patients.