A new COVID-19 antibody treatment developed by Eli Lilly just received an emergency use authorization from the Food and Drug Administration (FDA). The drug, bamlanivimab, is specifically authorized for use in people who have COVID-19 and are at high-risk for severe complications from the virus. It’s also one of a few drugs Chris Christie received while undergoing treatment for COVID-19 in October, the New York Times reported.
Bamlanivimab is a neutralizing monoclonal antibody therapy that falls under the umbrella of immunotherapy, meaning it can stimulate an immune system response by mimicking proteins the body makes naturally to fight off an infection. It consists of proteins designed to block part of SARS-CoV-2, the virus that causes COVID-19, from binding to one type of immune system cell in the human body. In this way, bamlanivimab may be able to block or treat the infection.
This particular COVID-19 antibody treatment does have some restrictions, per the FDA press release. For instance, it isn’t authorized to treat those who are already hospitalized or who require supplemental oxygen with COVID-19. Instead, it’s designed to be used in people who have the virus and are at a higher risk for needing to be hospitalized due to underlying conditions, age, or other risk factors. In this way, the hope is that using bamlanivimab will help keep those people from needing hospitalization. However, it is administered via an IV, so it’s not necessarily something people can take at home.
The drug received an emergency use authorization based on the results of an interim analysis of data from a phase 2 clinical trial. The data are for 465 people with mild to moderate COVID-19 who were not hospitalized. Of those participants, 156 received a placebo while the others received one of three doses of bamlanivimab within three days of their positive coronavirus test. Within 11 days, most patients—including those in the placebo group—had cleared the virus. But the results at this point showed that 3% of the high-risk patients in the bamlanivimab group were less likely to receive hospital treatment or have an emergency room visit in the 28 days following treatment compared to 10% of those participants in the placebo group.
Although those results are promising for people at a higher risk for COVID-19 complications, the results are from a trial that’s relatively small and still in phase 2. It will take more time and participants to know for sure how effective the drug really is. There are also concerns that the manufacturer won’t be able to make enough bamlanivimab to reach all the patients who need it. The company says it anticipates making 1 million doses by the end of the year for use around the world at the beginning of 2021. But estimates show we’re seeing 1 million new coronavirus cases every 11 days in the U.S. alone, suggesting it will be hard for Eli Lilly to keep up.
This isn’t the only antibody therapy for COVID-19 out there—Regeneron requested an emergency use authorization for its antibody treatment “cocktail” in October. (President Trump took Regeneron’s experimental drug while hospitalized earlier that month.)
As with remdesivir, convalescent plasma, and other treatment options we have now for COVID-19, this therapy alone will not solve the larger coronavirus pandemic. It may be a helpful option, particularly for people with underlying risk factors that make them more likely to need hospitalization, but simply having this option available is not enough. We need to keep up all the public health strategies we have to limit the effects of COVID-19, including wearing masks, social distancing, hand washing, widespread testing, contract tracing, and, eventually, an effective vaccine.