FDA rejects emergency use authorization for fluvoxamine: Ineffective in treating COVID-19
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FDA rejects emergency use authorization for fluvoxamine: Ineffective in treating COVID-19.
When the U.S. Food and Drug Administration (FDA) rejected an antidepressant as a treatment for COVID-19 on Monday, it also released a 27-page memo explaining exactly why this drug wasn’t believed to be effective.
It was an unusual move for the agency, which typically quietly refuses drugs without so much public documentation.
The antidepressant fluvoxamine is an inexpensive generic drug that has been used for decades. Research has shown that the drug can also block inflammation in the body.
As a result, some researchers hope it can help prevent severe symptoms in COVID-19 patients, some of whom have to deal with inflammation due to an overactive immune system.
Some small and preliminary studies suggest it may be able to reduce the risk of severe illness in people with COVID-19. But these studies were not enough to convince the FDA. In its memo, the agency said studies submitted in support of the drug did not adequately show that it could provide “clinically meaningful results” — reducing hospitalizations and deaths.
The main study, known as the Together trial, found that the drug reduced the likelihood that patients were in the emergency room for more than six hours. The FDA does not consider this metric important.
When the FDA rejects a drug, it’s uncommon to get this type of window into its decision-making process.
In most cases, the decision is in the hands of the pharmaceutical company that makes the drug, and it is kept secret. Research shows that these companies tend not to publish the results of rejections, and when they do, they don’t publicly explain why.
People do want to know, though: A survey of U.S. adults released in February found that nearly 90 percent said they wanted to make public information about a drug that wasn’t approved.
It’s worth noting that the use of fluvoxamine as a treatment for COVID-19 wasn’t submitted to the FDA by a pharmaceutical company — a group of doctors asked the agency to approve it. Because it is an ancient generic drug, no pharmaceutical company will profit from an expensive regulatory process.
FDA rejects emergency use authorization for fluvoxamine: Ineffective in treating COVID-19
(source:internet, reference only)
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