Merck asking FDA for emergency-use authorization for COVID treatment pill
ORLANDO, Fla. - A pill you can take to treat COVID-19 may soon be a reality.
The news came Monday morning that drugmaker Merck is asking the Food and Drug Administration (FDA) to greenlight emergency authorization for its COVID-19 pill, Molnupiravir.
"Basically, an emergency-use authorization is a setting where there is an urgency to treat people because of the morbidity and mortality that is happening for any disease. In this case, COVID-19," said Orlando physician Dr. Jason Littleton.
Dr. Jason Littleton says the five-day drug will treat mild-to-moderate cases of the virus in people who are at high risk for hospitalization.
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"This is game-changing. By giving a pill, people who test positive, instead of going to the hospital, instead of using alternative treatment, this is an opportunity where they can take a pill that can reduce the viral load that a patient has," Dr. Littleton added.
The company submitted for emergency approval after seeing positive results from a trial that showed patients who took the drug within five days of symptoms had about half the rate of hospitalization and death than the group that received a dummy pill.
The FDA will look at the company data to analyze the safety and effectiveness of the drug before making its decision.
It's a process that could take a few months for approval.
Dr. Littleton says it’s important to note that this pill is not a preventive measure for COVID-19.
It’s another tool in the toolbox for treatment.
"It is really about having a multi-approach and giving options to people. I think that is important because the goal really is to reduce mortality or morbidity really by any means," Dr. Littleton said. If approved, the company says it plans to pump out 10 million treatments by the end of the year.
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