U.S. regulators have rejected a request to grant emergency authorization to a cheap drug for the treatment of COVID-19, drawing criticism from one of the doctors that asked for the clearance.
The Food and Drug Administration (FDA), in a 27-page memorandum explaining its decision, said that the benefit of fluvoxamine was “not persuasive when focusing on clinically meaningful outcomes such as proportion of patients experiencing hospitalizations or hospitalizations and deaths.”
A review of clinical trials that have examined fluvoxamine, a widely used antidepressant, against COVID-19 led to the conclusion that the data at this time are insufficient for emergency clearance, the FDA added….