The Food and Drug Administration issued an "emergency use authorization" for convalescent plasma as a treatment of Covid-19 in hospitalized patients, the administration said on Sunday.
The FDA said that based on the scientific evidence currently available, it has concluded the antibody-rich plasma "may be effective" in treating Covid-19. It also concluded that the potential benefits outweigh the potential risks.
Several companies are working on products using the technology or that are related to the technology, including Japanese drugmaker Takeda (TAK) - Get Takeda Pharmaceutical Co. Ltd. Report, Emergent BioSolutions (EBS) - Get Emergent BioSolutions Inc. Report and Regeneron (REGN) - Get Regeneron Pharmaceuticals, Inc. Report.
In Takeda's plasma-derived therapy, dubbed TAK-888, for example, the therapy would be similar to plasma-based treatments previously used on other severe acute viral infections, including during the Ebola crisis. It's also based on technology believed to date back as far as the flu of 1918.
By concentrating the virus-specific antibodies from plasma collected from people who have already recovered from Covid-19, the disease caused by the newly discovered coronavirus, the plasma therapies could be used to treat severely ill patients and -- possibly -- help their at-risk health care workers develop immunity, Takeda told TheStreet earlier this year.
It's not clear how the authorization would impact these companies, but it's widely believed the therapies would only be reserved for the most severely ill.
"Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing," said the FDA in a statement.
The emergency authorization would OK distributing the convalescent plasma in the U.S. and its use by health care providers.
“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from Covid-19,” said Alex Azar, Health and Human Services Secretary.
Trump earlier over the weekend made claims over Twitter that the "deep state" or others at the FDA were trying to slow the approval of coronavirus vaccines and therapies.