COVID-19 and Monoclonal Antibodies – Emergency Use Authorization for Bamlanivimab
The FDA’s Emergency Use Authorization to treat high risk COVID-19 patients with the monoclonal antibody bamlanivimab will offer limited availability in Texas, where only 6,000 government doses are expected next week. Houston Methodist’s Dr. Howard J. Huang said most patients’ best chance to receive this new drug will come through clinical trials like the BLAZE-1 randomized, placebo-controlled Phase 2 study, one of which he heads at Houston Methodist. “Even if we wanted to give it to everybody, there are initially only 300,000 doses available for the entire country under the EUA,” said Huang, principal investigator of the BLAZE-1 study at Houston Methodist and a specialist in transplant pulmonology.
Bamlanivimab has been shown to reduce hospitalizations and emergency room visits for high risk COVID-19 patients. Huang says the limited supply of the drug is analogous to the Remdesivir EUA last summer in which hospitals around the country had to try to help as many COVID patients as possible with limited doses available.