FDA Approves Emergency Use of Nation’s First Drug Treatment Against COVID-19
This week, the US Food and Drug Administration (FDA) approved the emergency use of the antiviral remdesivir as the country’s first drug treatment for COVID-19.
The crisis use endorsement (EUA) was given after a legislature supported investigation of 1,063 patients found that hospitalized COVID-19 patients treated with the medication recouped a normal of 4 days quicker than the individuals who were not treated with the medication—a 31% improvement in recuperation time.
The treatment, which was developed by Gilead Sciences Inc., may be approved for expanded use provided that additional research can be conducted on the efficacy and safety of the drug.
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.
“From the very first moment, the FDA has been focused on speeding up the turn of events and accessibility of potential COVID-19 medications. The present activity is a significant advance in our endeavors to work together with trend-setters and specialists to give debilitated patients opportune access to new treatments where fitting, while simultaneously supporting examination to additionally assess whether they are protected and viable,” said FDA Commissioner Stephen M. Hahn.
“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” he added.
In view of assessment of the crisis use approval measures and the logical proof accessible, it was resolved that it is sensible to accept that remdesivir might be viable in treating COVID-19, and that, given there are no satisfactory, endorsed, or accessible elective medications, the known and potential advantages to treat this genuine or perilous infection as of now exceed the known and potential dangers of the medication’s utilization.
“The results from the global, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases (NIAID) are positive. They show that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo,” said Gilead Chairman and CEO Daniel O’Day in a statement.
“There is still more work to do and remdesivir has not been affirmed, however we all at Gilead are lowered by what these promising outcomes may mean for patients. Following quite a while of research and difficult work on remdesivir, there is help and appreciation among our groups today that their endeavors have been so advantageous.
“Since January, our teams have been working day and night to determine whether remdesivir might work in patients with COVID-19. These efforts include collaboration with study investigators and governments on the various clinical trials. Today’s news, that remdesivir might play a role in easing the burden of the pandemic, is the outcome we all hoped would be possible.”
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