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Remdesivir Authorized

Published on May 13th, 2020

The Food and Drug Administration has granted remdesivir emergency use authorization to treat the most severely ill COVID-19 patients. The emergency use authorization is not the same as FDA approval.  It is not considered a cure.

The FDA action specifies the drug may be used for both adults and children with suspected or confirmed COVID-19 diagnoses who are severely ill with low blood oxygen levels or who may be on a ventilator. However, that does not mean the drug should be used for all hospitalized patients.

“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,” the FDA wrote in a press release.

The FDA’s decision expands doctors’ ability to use remdesivir on the most severe cases. Previously, physicians were limited to trying the drug in clinical trials or in what’s called compassionate use for patients who have no other treatment options. It has only been used for the most severe cases of COVID-19, and is only administered through an IV.

The FDA’s emergency use authorization increases access by allowing any doctor “to prescribe remdesivir for their patients who are hospitalized with COVID-19,” Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, explained.

The FDA wrote that possible side effects include, “increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.”

O’Day said the company hopes to expand usage for patients earlier in the course of illness, before patients become sick enough to be hospitalized. Future methods of remdesivir delivery could include an injection or inhaler, but that would likely take months or even years to develop.

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