FDA Approves First COVID-19 Treatment
“We now have enough knowledge and a growing set of tools to help fight COVID-19.”
The Food and Drug Administration has approved the first COVID-19 treatment, antiviral drug remdesivir, for hospitalized patients.
The FDA announced the approval Thursday for use of the drug in adults and children over 12 years old and weighing at least about 88 pounds.The agency previously authorized emergency use of the drug in May.
The previous authorization indicated the FDA was willing to greenlight the use of an unapproved medical product or an unapproved use of an approved medical product during a serious public health emergency like the coronavirus pandemic.
Gilead Sciences, an American biotech company, makes remdesivir and sells it under the brand name Veklury. The company studied the drug as a possible treatment for Ebola during the 2014 outbreak and for other coronaviruses such as SARS and MERS.
A large clinical trial by the U.S. Institute of Allergy and Infectious Diseases found remdesivir could reduce recovery time in COVID-19 patients by five days, from a median of 15 to 10.
“In less than one year, the world has moved from a sense of desperation to understand an unknown disease spreading all too quickly and taking lives,” Merdad Parsey, chief medical officer at Gilead said in a statement Thursday, “to one of hope that we now have enough knowledge and a growing set of tools to help fight COVID-19.”
About 50 countries have granted approval or temporary authorization of the drug, Parsey said. He added that the company will have enough supply “to treat all clinically appropriate patients globally next week.”
After President Donald Trump was diagnosed with COVID-19, he received remdesivir.