The Food and Drug Administration on Sunday is expected to authorize use of convalescent plasma, the antibody-rich blood taken from recovered Covid-19 patients, for the treatment of serious coronavirus cases, a person familiar with the matter said.
President Trump is also expected to discuss the move at a news conference later Sunday, the person said.
The agency’s action, called an emergency-use authorization, would permit use of the treatment on hospitalized Covid-19 patients within three days of diagnosis, the person said. The Wall Street Journal reported last month the move was coming.
For Covid-19 patients and the doctors who treat them, the designation opens up the possibility for faster and easier access to a promising treatment, while studies and clinical trials continue to explore who is helped and how much.
Read More
- Convalescent Plasma Reduced Death Rate Among Covid-19 Patients, Study Data Signals (Aug. 4)
- FDA Nears Decision Authorizing Covid-19 Treatment With Convalescent Plasma (July 29)
- Study Points to Efficacy of Convalescent Plasma for Covid-19 (May 22)
- FDA Authorizes Emergency Use of Gilead Drug Remdesivir for Covid-19 Patients (May 1)
Doctors have been looking for validated coronavirus treatments. The antiviral remdesivir, from Gilead Sciences Inc., has the FDA’s emergency-use authorization.
Convalescent plasma has been seen as a way to help people fight the disease, serving as a bridge while other treatments are under development. The emergency-use authorization doesn’t alleviate the need for a vaccine or for therapies known as monoclonal antibodies that could stave off infection or at least reduce the seriousness of one.
Emergency-use authorization waives some regulatory requirements involved in using products during public-health emergencies that aren’t yet FDA approved.
Write to Thomas M. Burton at tom.burton@wsj.com and Amy Dockser Marcus at amy.marcus@wsj.com
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