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), XBiotech (XBIT +5.0%)

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