FDA grants emergency approval to experimental COVID-19 antibody therapy
The U.S. Food and Drug Administration (FDA) has just approved the first coronavirus-specific antibody treatment for moderate cases of COVID-19. The focused Emergency Use Authorization (EUA) is aimed at newly diagnosed infections at the highest risk of progressing to severe disease.
Back in early October monoclonal antibody therapies hit the mainstream after Donald Trump touted them as a “cure” and primarily responsible for his rapid recovery from COVID-19. Now, the FDA has formally issued an EUA allowing specific patients access to one of these experimental antibody therapies in development.
The newly announced FDA approval is not for the Regneron antibody therapy Donald Trump was administered, but instead it focuses on bamlanivimab, a different investigational antibody developed by pharmaceutical company Eli Lilly.
“Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses,” the FDA explains in its EUA announcement. “Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.”
This FDA authorization is based on Phase 2 trial data showing bamlanivimab reduces disease severity and rates of hospitalization in patients if administered early in the course of the disease. Importantly, the FDA notes that bamlanivimab is not a treatment for severe hospitalized patients, and trial indications suggest these kinds of monoclonal antibody therapies may worsen outcomes if administered to patients in later stages of the disease.
The EUA issued by the FDA is clear in stating bamlanivimab is only approved for use in patients over the age of 12 and at a high risk of severe disease. The approval is also limited to those patients at the very earliest stages of the disease. Eli Lilly suggests the treatment should be administered as soon as possible after a positive COVID-19 test, and no later than 10 days after symptoms have appeared.
"The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," says Daniel Skovronsky, Lilly's chief scientific officer in a statement.
Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, notes this EUA is a temporary approval. Clinical trials are still ongoing and formal approval processes will evaluate broader data as it becomes available.
“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” says Cavazzoni. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”
Eli Lilly say 300,000 doses of bamlanivimab have already been made available to the US government for immediate distribution across the country. Another one million doses should be available to the rest of the world by the end of 2020 with manufacturing expanding in early 2021.