U.S. FDA Issues Emergency Authorization for Convalescent Plasma Treatment
An emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 disease in hospitalized patients was issued by the U.S. Food and Drug Administration.
The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by healthcare providers to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.
With the Mayo Clinic facilitating various study sites, over 70,000 patients have already been treated with convalescent plasma in 2020.
This announcement on August 23, 2020, is part of the agency’s ongoing efforts to fight the COVID-19 pandemic. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, ‘this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.’
Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.
The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.
Stephen M. Hahn, M.D., FDA Commissioner said in a press statement: “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma.”
“The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus.”
“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,” said Dr. Hahn.
This new 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 currently available evidence.
The FDA initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications.
As the number of single-patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol.
The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for the prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
The FDA is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
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