Experimental drug gets US FDA nod for emergency use

Experimental drug gets US FDA nod for emergency use

Remdesivir’s trial achieved a “proof of concept,” according to Fauci

The US Food and Drug Administration (FDA) has approved the use of an experimental drug Remdesivir for emergency use against COVID-19, President Donald Trump said.

The approval was given after clinical trials showed that the antiviral drug from Gilead Sciences shortens the recovery period in some coronavirus patients.  It is the first medicine to show such results against the novel coronavirus.

“It is really a really promising situation,” Trump said at the White House. He was joined by Gilead’s CEO Daniel O’Day.

“We are humbled with this first step for hospitalized patients,” said O’Day, adding: “We want to make sure nothing gets in the way of these patients getting the medicine.”

The company previously announced it will donate 1.5 million doses for free which equals to nearly 140,000 treatment courses based on a 10-day treatment duration.

The injectable medication was previously available to limited patients enrolled in its clinical trials. It was also given out on “compassionate use” basis.

The new authorization will allow the drug to be distributed extensively for use for both adults and children affected severely by COVID-19, and are hospitalized.

FDA defines severe as having low blood oxygen levels, requiring oxygen therapy, or being on a ventilator. The US National Institute of Allergy and Infectious Diseases (NIAID) announced the results of a trial involving more than 1,000 people earlier in the week.

It found that hospitalized COVID-19 patients with respiratory distress got better quicker than those on a placebo. Specifically, patients on the drug had a 31 percent faster time to recovery.

“Although the results were clearly positive from a statistically significant standpoint, they were modest,” Anthony Fauci, the scientist who leads the NIAID told NBC News on Thursday. “While not considered a miracle cure, remdesivir’s trial achieved a “proof of concept,” according to Fauci that could pave the way for better treatments.

Remdesivir incorporates itself into the virus’s genome, short-circuiting its replication process. It was first developed to treat Ebola, a viral hemorrhagic fever, but did not boost survival rates as other medicines.

Currently, there are over 913,000 active coronavirus cases in the United States with nearly 67,000 deaths.

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