Unpersuaded by the data, FDA rejects cheap, generic SSRI as a Covid-19 drug
Fluvoxamine, an SSRI already FDA-approved as an OCD treatment, appeared to show some hints of efficacy in Covid-19 too, leading University of Minnesota ID doc David Boulware last December to submit an EUA for it as an outpatient treatment for those testing positive and to prevent the progression to hospitalization.
Almost 6 months later, the FDA said Monday it’s rejecting the cheap generic drug’s Covid-19 EUA as the primary RCT from Brazil, on which the majority of the app rests: “The treatment benefit of fluvoxamine was not persuasive when focusing on clinically meaningful outcomes such as proportion of patients experiencing hospitalizations or hospitalizations and deaths.”
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