FDA rejects old antidepressant Luvox as COVID treatment citing lack of evidence
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The U.S. FDA declined to approve an Emergency Use Authorization (EUA) request to use the antidepressant Luvox (fluvoxamine) as a COVID-19 therapy stating the treatment benefit of the drug "was not persuasive when focusing on clinically meaningful outcomes."
The request was filed in December by David Boulware, an infectious disease physician with the University of Minnesota Medical School. He relied on data from three studies conducted in Brazil. The largest one, TOGETHER, enrolled ~1500 non-hospitalized patients with COVID. The other two were also in a non-hospitalized population.
The FDA said that even though TOGETHER met its primary endpoint -- a composite measure of emergency room visits due to COVID worsening and hospitalization due to progression of the disease -- "there are uncertainties about the assessment of this endpoint."
The agency also noted that Gilead Sciences' (NASDAQ:GILD) Veklury (remdesivir) is already approved for non-hospitalized individuals, and Pfizer's (NYSE:PFE) Paxlovid and Merck's (NYSE:MRK) Lagevrio (molnupiravir) have been authorized.
Also, Eli Lilly (NYSE:LLY)/AbCellera Biologics' (ABCL) bebtelovimab, a monoclonal antibody, is authorized for adults and children 12 and older who test positive for COVID and who are at high risk for progressing to severe disease.
In April, the CDC listed Veklury and Paxlovid as preferred therapies for non-hospitalized patients.