Cerus Corp. has received the green light from the U.S. FDA for its Intercept blood system for cryoprecipitation. The device, which garnered a breakthrough device designation in 2018, is used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PR-Cryo) for treating and controlling bleeding, including massive hemorrhage, associated with fibrinogen deficiency.
As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.
Cerus Corp., of Concord, Calif., is teaming up with several collaborators in its home state, with an eye toward optimizing convalescent plasma therapy for COVID-19 patients.