FDA will reportedly authorize use of remdesivir after founding potentials

FDA will reportedly authorize use of remdesivir after founding potentials
Dr. Fauci said the drug has strong potentials. Source: POOL
3 Min Read

Daily US Times: On Wednesday, researchers released some good news about a possible treatment for Covid-19- after evidence shows that experimental drug remdesivir might help patients recover more quickly from the infection.

According to the New York Times, the FDA (Food and Drug Administration) has not yet approved any drugs for the coronavirus treatment but considering announcing an emergency-use authorization for remdesivir.

FDA said in a statement that it is in talks with Gilead Sciences, the maker of remdesivir, about making the drug available to patients.

In the statement sent to CNN, FDA spokesman Michael Felberbaum said: “As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in … discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.”

The government-funded study found that patients who took remdesivir recovered faster than patients who did not.

The pandemic worst hit in the US, infected more than 1 million Americans and killed close to 60,000 people.

Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases was optimistic about the results.

Remdesivir has a clear-cut effect

Dr. Fauci said “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.”

Preliminary trial results show that the drug improved recovery time for coronavirus patients from 15 to 11 days. That’s similar to the effect that the influenza drug Tamiflu has on flu.

Tamiflu also doesn’t cure patients quickly, but can reduce the sickness time of the patient.

Fauci said of remdesivir: “Although a 31% improvement doesn’t seem like a knockout 100%, it is very important proof of concept.”

“What it has proven is that a drug can block this virus.”

Remdesivir also may reduce the likelihood that patients will die.

The NIAID said that trial results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.

Normally, a drug’s efficiency wouldn’t be released too early, but Dr. Fauci said: “whenever you have clear-cut evidence that a drug works, you have an ethical obligation to immediately let the people in the placebo group know so that they can have access.”

There have been several drugs being tested for the cure of coronavirus, Remdesivir is one of them.

Fauci said 1,090 people participated in the trial internationally, calling it “the first truly high-powered randomized placebo controlled trial.”

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