Redsiwe is authorized for emergency use by fda in the United States

May 1 U.S. time, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the antiviral drug remdesivir, which is used to treat hospitalized patients with severe new coronavirus pneumonia. According to EUA, the recommended treatment time is 5 and 10 days, depending on the severity of the disease.The EUA is based on available data from two global clinical trials - the placebo-controlled Phase III trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) for patients with moderate to severe new coronavirus pneumonia, including critically ill patients, and the global Phase III trial of Rydersiwe's 5-day and 10-day dosage time in Gilead's assessment of critically ill patients.Related reading: Redsyvir clinical data three consecutive U.S. and Chinese results are very different Redsyvir must be administered intravenously, the optimal dose and duration of its use for the treatment of new coronavirus pneumonia is not yet clear. Under EUA, the recommended dosing time is 10 days for patients requiring invasive mechanical aeration and/or in-body pulmonary membrane oxygenation (ECMO) and 5 days for patients who do not require invasive mechanical aeration and/or ECMO. If the patient who was given the drug for 5 days did not show clinical improvement after 5 days, the treatment time of up to 5 days (a total of 10 days) can be extended.As previously announced, Gilead has donated all of its existing available supplies, both finished and unfinished, to help address the urgent medical needs resulting from the sub-global pandemic. Based on a 10-day course of treatment, Gilead's donation of 1.5 million doses of Redsywe, after this emergency use authorization and potential other emergency authorizations and regulatory approvals, will provide patients with the equivalent of more than 140,000 treatments free of charge.The EUA is temporary and does not replace the formal procedures for submitting, reviewing and approving new drug applications. Emergency use authorization only allows the distribution and emergency use of Redsyvir for the treatment of new coronavirus pneumonia; Redsyvir is still a drug under study and has not yet been approved by the FDA.The European Medicines Agency (EMA) has also announced that its Human Drug Commission (CHMP) has begun a rolling review of data from Redsyvir's treatment COVID-19.In addition, Japanese Prime Minister Shinzo Abe said Japan would soon approve Redsiwe for the treatment of COVID-19 patients, Kyonhap reported. Another government official said separately that the drug could be approved as early as May for the treatment of respiratory diseases caused by the new coronavirus in patients with COVID-19.
(Sina Pharmaceutical News)