FDA Launches Effort To Develop Blood-related Therapies For COVID-19
The U.S. Food and Drug Administration (FDA) launched a national effort to facilitate the development of blood-related therapies to combat the ongoing coronavirus (COVID-19) pandemic.
The FDA is focused on two investigational therapies derived from human blood called convalescent plasma and hyperimmune globulin, which are antibody-rich blood products made from blood donated by people who have recovered from COVID-19. Hyperimmune globulin is a biological product manufactured from convalescent plasma.
The products can be administered to individuals diagnosed with COVID-19. Meanwhile, there are only some limited data to suggest that these may help in preventing or treating the COVID-19 illness. The FDA is pushing for the evaluation of these therapies in the context of a clinical trial and expanded access program.
Based on data on prior experience with respiratory viruses that have emerged from China, these products have the potential to lessen the severity or shorten the length of illness caused by COVID-19.
The FDA is facilitating expanded access to convalescent plasma for treating COVID-19 using multiple pathways by organizing a partnership between industry, academic institutions, and government agencies.
The agency’s initial effort was focused on facilitating access to convalescent plasma for the treatment of COVID-19 disease through an emergency investigational new drug application (eIND) process.
Further, the agency is working with industry and its government partners to accelerate the development and availability of hyperimmune globulin for investigation for the potential treatment COVID-19.
The FDA has selected Mayo Clinic to serve as the lead institution for the program and the American Red Cross will help collect plasma and distribute it for use in patients across the country.
The FDA has encouraged people who have fully recovered from COVID-19 for at least two weeks to consider donating plasma, which could potentially help save the lives of up to four patients.
The FDA anticipates that this collaborative effort will be able to move thousands of units of plasma to the patients who need them in the coming weeks.
Across the United States, confirmed coronavirus cases have exceeded 337,900 and the death toll has risen to over 9,600, as of this writing. New York continues to be the worst-hit state in the U.S. Worldwide, more than 1,286,400 people have been infected and over 70,300 people have died of the novel coronavirus so far, according to Johns Hopkins University data.
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