FDA Issues Emergency Use Authorization for Remdesivir

HealthDay News – The US Food and Drug Administration has granted an emergency use authorization for remdesivir to treat hospitalized patients with suspected or confirmed COVID-19, the agency announced Friday.

The agency noted that data on the safety and efficacy of remdesivir are limited, but preliminary results from a National Institutes of Health-sponsored clinical trial released this week showed that remdesivir shortened the time to recovery in some patients. “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,” the FDA wrote in a statement. “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.”

Under the emergency use authorization, remdesivir can be distributed in the United States and administered intravenously as appropriate to treat suspected or laboratory-confirmed COVID-19 in adults and children with severe disease, defined as low blood oxygen levels or the need for oxygen therapy or more intensive breathing support such as a mechanical ventilator.

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A requirement under the emergency use authorization is that health care providers and patients are provided with fact sheets on using remdesivir in COVID-19 treatment. These fact sheets contain information on dosing instructions, potential side effects, and drug interactions. Possible side effects include increased liver enzymes and infusion-related reactions, such as low blood pressure, nausea, vomiting, sweating, and shivering.

The emergency use authorization was issued to Gilead Sciences.

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