APhA coronavirus watch: FDA works toward blood-related treatments of ‘devastating disease’
FDA has recently announced two efforts towards treating the coronavirus involving the blood of those who have recovered and those with confirmed or imminent respiratory failure caused by the disease.
On April 3, 2020, FDA said in a press release that it will coordinate development of the use of two products, convalescent plasma and hyperimmune globulin, in the treatment of those with COVID-19. FDA has facilitated access of the products through an emergency investigational new drug application process and clinical trials conducted at academic institutions. The products are derived from human blood donated by people who have recovered from the virus and may have the potential to lessen the severity or shorten the length of illness caused by COVID-19.
On April 10, 2020, FDA issued an emergency use authorization for a blood purification system on patients 18 years and older who were diagnosed with COVID-19 and admitted to ICUs. The purification system will reduce the level of cytokines and other inflammatory mediators in the patient’s blood, and then return the filtered blood to the patient. “With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease,” FDA Commissioner Stephen M. Hahn, MD, said in a press release.