By NewsDesk @infectiousdiseasenews
On Wednesday, the National Institutes of Health (NIH) reported that preliminary data analysis from a clinical trial on the investigational antiviral drug, remdesivir, showed hospitalized patients with advanced COVID-19 and lung involvement who received the drug recovered faster than similar patients who received placebo.
The same day, National Institute of Allergy and Infectious Diseases (NIAID) head, Dr. Anthony Fauci said, “The data shows that remdesivir has a clear-cut and significant positive effect in diminishing the time to recovery”. He called the early findings from the National Institute of Allergy and Infectious Diseases “highly significant.”
On Friday, the US Food and Drug Administration (FDA) issued an emergency use authorization for remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” said HHS Secretary Alex Azar. “NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19. The seamless cooperation between government and private industry under the President’s all-of-America approach to COVID-19 is getting treatment options to patients in record time.”
The EUA allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.
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