FDA yesterday approved etranacogene dezaparvovec (Hemgenix, CSL Behring), an adeno-associated virus vector-based gene therapy for the treatment of adults with hemophilia B (congenital factor IX deficiency) who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. This product is a one-time gene therapy product given as a single dose by intravenous infusion. The viral vector carries a gene for clotting factor IX.
FDA also yesterday issued an emergency use authorization for the Lucira COVID-19 and Flu Test for use in a point-of-care (POC) setting, following collaboration with the NIH Independent Test Assessment Program (ITAP). The product is a single-use molecular test intended for the detection of both the SARS-CoV-2 virus and influenza (A or B) if a patient is suspected of respiratory viral infection consistent with COVID-19. The test can be used in persons aged 2 years or older and is collected by nasal swab by a healthcare provider in a POC setting. Negative test results should be confirmed with another FDA-authorized molecular test. Negative test results must be combined with clinical observations, patient history, and epidemiological information.