When the US Food and Drug Administration rejected an antidepressant as a treatment for COVID-19 on Monday, it also released a 27-page memo explaining exactly why it was not convinced the drug was effective. It’s an unusual move for the agency, which typically turns down drugs quietly without much publicly available paperwork.
The antidepressant fluvoxamine is a cheap generic drug that has been used for decades. Research shows that the drug can also block inflammation in the body. So some researchers hoped it might help prevent severe symptoms in COVID-19 patients, some of whom have to deal with inflammation due to overactive immune systems.
Some small, preliminary studies showed that it might reduce the risk of COVID-19 patients getting seriously ill. But that investigation was not enough to convince the FDA. The agency said in its memo that the studies submitted to support the drug did not do enough to show that it could deliver “clinically meaningful results” — reduced hospitalizations and deaths. The main study, called the Together trial, found that the drug reduced the likelihood that a patient would be in the emergency room for more than six hours. The FDA wasn’t sure the metric was important.
It’s rare to have this kind of window into the FDA’s decision-making process when it rejects a drug. Most of the time, the decision rests with the pharmaceutical company that made the drug and is kept confidential. Research shows that these companies often don’t announce rejections, and if they do, they don’t publicly say why. People do want to know, though: A survey of adults in the United States released in February found that nearly 90 percent said they would want information on why a drug was not approved for publication.
In particular, 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 authorize it. Because it is an old, generic drug, no drug company would benefit from putting it through the costly regulatory process.
One of those doctors, University of Minnesota infectious disease specialist David Boulware, criticized the FDA rejection, saying CONDITION it was “inconsistent”. He noted that the coronavirus antiviral paxlovid is more effective, but is not widely available to people in low- and middle-income countries. “He’s not my first choice as a doctor, but he should have the choice,” Boulware said.