According to the verge report, when the U.S. Food and Drug Administration (FDA) on Monday refused When using an antidepressant as a treatment for covid-19, it also issued a 27 page memo that accurately explained why it did not believe the drug was effective** This is an unusual move for the agency, which usually quietly rejects drugs without so many public documents.
Fluvoxamine, an antidepressant, is a cheap common drug that has been used for decades. Studies have shown that the drug can also block inflammation in the body. Therefore, some researchers hope it can help prevent severe symptoms in covid-19 patients, some of whom have to deal with inflammation due to overactive immune system.
Some small and preliminary studies have shown that it may reduce the risk of serious diseases in covid-19 patients. But these studies are not enough to convince the FDA. The agency said in its memorandum that the study submitted to support the drug did not fully show that it could provide "clinically meaningful results" - reducing hospitalization and death. The main study, called the together trial, found that the drug reduced the likelihood of patients being in the emergency room for more than six hours. The FDA does not consider this indicator important.
When FDA rejects a drug, it is not common to get this type of window to understand its decision-making process. In most cases, the decision is in the hands of the pharmaceutical company that makes the drug and is confidential. Research shows that these companies often do not publish the results of rejection, and even if they do, they do not publicly explain the reasons. However, people do want to know: a survey of American adults released in February found that nearly 90% said they wanted to disclose information about a drug that was not approved.
It is worth noting that the use of fluvoxamine as a treatment for covid-19 was not 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 expensive regulatory procedures.
One of the doctors, David Boulware, an infectious diseases doctor at the University of Minnesota, criticized the FDA's rejection, telling stat it was "inconsistent". He pointed out that the coronavirus antiviral drug paxlovid is more effective, but it cannot be widely used by people in low - and middle-income countries. "As a doctor, this is not my first choice, but I should have this choice," Boulware said