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The FDA on Sunday issued an emergency use authorization to allow treatment with COVID-19 convalescent plasma for patients who are hospitalized with the disease.
The FDA on Sunday issued an emergency use authorization (EUA) to allow treatment with COVID-19 convalescent plasma (CCP) for patients who are hospitalized with the disease.
The FDA opted to do this based on the available scientific evidence.
In an executive summary of the decision memorandum, the FDA stated that after consideration of all of the evidence in the EUA, the administration concluded that the current data regarding use of this treatment in hospitalized patients meets the “may be effective” criterion for issuance of the EUA.
The FDA described CCP as an unapproved biological product that is “a passive immune therapy for the treatment of hospitalized patients with COVID-19.”
According to the FDA statement, the FDA based its decision to allow distribution of CCP to hospitalized patients with COVID-19 in the US and administered by health care providers based on the following:
“The sponsor has pointed to four lines of evidence to support that CCP may be effective in the treatment of hospitalized patients with COVID-19: 1) History of convalescent plasma for respiratory coronaviruses; 2) Evidence of preclinical safety and efficacy in animal models; 3) Published studies of the safety and efficacy of CCP; and 4) Data on safety and efficacy from the National Expanded Access Treatment Protocol) sponsored by the Mayo Clinic.”
The summary added that it is reasonable to conclude that the known and potential benefits of CCP outweigh the known and potential risks of CCP for the proposed EUA.
“Current data suggest the largest clinical benefit is associated with high-titer units of CCP administered early in the course of disease,” the summary indicated.
“Adequate and well-controlled randomized trials remain necessary for a definitive demonstration of CCP efficacy and to determine the optimal product attributes and appropriate patient populations for its use.”
According to FDA Commissioner Stephen M. Hahn, MD, officials were encouraged by the early promising data that they have seen about convalescent plasma.
“The data from studies conducted this year shows that plasma from patients who have recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” he said in a statement. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
The FDA noted that the EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma.
“The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence,” the summary concluded.