The Food and Drug Administration (FDA) on Friday has granted an emergency use authorisation to Gilead Science's drug Remdesivir to treat severely ill COVID-19 patients, announced US President Donald Trump during an Oval Office meeting with HHS Secretary Alex Azar, FDA commissioner Dr. Stephen Hahn, and the CEO of Gilead Sciences. This decision expands the doctors' ability to use the drug for treating patients.
The FDA in its official release has specified that the drug can be used for both adults and children who are severely ill due to the Coronavirus with low blood oxygen levels or those who are on the ventilator. It further added that given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat the serious or life-threatening virus currently outweigh the known and potential risks of the drug's use.
Meanwhile, FDA director of the Center for Drug Evaluation and Research Dr. Janet Woodcock took to Twitter and clarified that the emergency use authorisation is not the same as the FDA Approval.
An EUA is not the same as FDA approval. Under the EUA, health care providers and patients are provided with information about the risks of remdesivir.— Dr. Janet Woodcock (@DrWoodcockFDA) May 1, 2020
HCP Fact Sheet: https://t.co/BmK7667Q6s
Patient Fact Sheet: https://t.co/YBGQMIHkUM
According to reports, the FDA has stated that the drug may have possible side effects that may include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver, low blood pressure, nausea, vomiting, sweating, and shivering.
The National Institutes of Health (NIH) on April 29 stated that the patients who have received Remdesivir recovered faster than those who received Placebo for coronavirus treatment. According to the NIH release, it stated, "Hospitalized patients with advanced COVID-19 and lung involvement who received Remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1063 patients, which began on February 21."
It further added, "Patients who received Remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). The time taken to recover deferred as well, with 11 days for those treated with Remdesivir compared with 15 days for those who received Placebo." NIH is a body under the U.S. Department of Health and Human Services.
News: NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19 https://t.co/yUIfl8LNau— NIH (@NIH) April 29, 2020