The US FDA approved the emergency use of Remdesivir in treating patients with severe COVID-19.
US FDA — The Food and Drug Administration in the United States approved the emergency use of Remdesivir in treating patients with severe COVID-19.
This, as US Food and Drug Administration Commissioner Stephen Hahn said that the experimental drug, Remdesivir, was the “first” authorized drug in treating COVID-19 in the United States, adding that the approval of the said drug was “an important clinical advance” that presented a “statistically significant” in shortening the time of recovery for patients with coronavirus.
The Food and Drug Administration in the United States issued an emergency-use authorization which stated that the benefits of Remdesivir outweigh coronavirus risks in infected patients. Although an emergency-use authorization was different from a full FDA approval.
A chief scientist of the US Food and Drug Administration, Denise Hinton, said in an authorization letter that there was “no adequate, approved, and available alternative” to the emergency use of the said drug in treating COVID-19 patients.
As per the report, the US Food and Drug Administration limited the authorization of Remdesivir to those patients with suspected or confirmed COVID-19 severe disease. However, the US FDA said that the possible side effects of the authorized therapy drug include infusion-related reactions and increased levels of liver enzymes.
In a letter from the Food and Drug Administration in the United States, it said that the federal government will control the distribution of Remdesivir in order to use the said drug with “terms and conditions” of the authorization.
Daniel O’Day, chief executive officer of Gilead Sciences, thanked the caregivers and patients who participated in the early clinical trials of Remdesivir.
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