FDA announces initiatives for antibody blood products for COVID-19

Aimed at facilitating nationwide access to antibody-rich blood products for COVID-19 patients, the FDA has instituted an emergency investigational new drug application (eIND) process for convalescent plasma, with its SARS-CoV-2 antibodies, collected from people who have recovered from the infection.

Based on prior history with respiratory viruses and data from China, convalescent plasma and its more refined relative, hyperimmune globulin (concentrated SARS-CoV-2 antibodies), may shorten the recovery time for severely ill patients.

The agency says it has provided information to healthcare providers on how to submit applications for clinical studies at academic institutions.

The Mayo Clinic will serve as lead institution while the American Red Cross will help with plasma collection and distribution.

Selected tickers: Emergent BioSolutions (EBS +1.4%), ADMA Biologics (ADMA +8.5%), Kamada Ltd. (KMDA)

https://seekingalpha.com/news/3558318-fda-announces-initiatives-for-antibody-blood-products-for-covidminus-19