COVID-19 Monoclonal Antibodies Still Aren’t Widely Used, but New EUA Could Improve Utilization

The U.S. has secured a hefty supply of COVID-19 monoclonal antibodies, but challenges in administering the potentially game-changing treatments and skepticism around their efficacy have contributed to their minimal use. Now, a newly issued Emergency Use Authorization (EUA) for an antibody combo could inspire greater assurance in the drugs as potential treatments for preventing hospitalization.

The FDA this week granted an EUA for Eli Lilly’s bamlanivimab (700mg)/etesevimab (1400mg) combination therapy, allowing the drugs to be used for treating mild-to-moderate COVID-19 in patients 12 years and older at high risk of progressing to severe infection.

The agency’s decision was supported by results from a phase 3 clinical trial that showed a single intravenous (IV) infusion of the combo had a significant impact on reducing hospitalizations and deaths during 29 days of follow-up compared to placebo.

The agency granted bamlanivimab an EUA in November 2020 for the same indication and patient group. That authorization generated some skepticism and confusion because of the three dosages researchers studied the FDA only authorized a 700-mg dose despite only a 2,800-mg dose meeting the trial’s endpoint (DID, Nov. 12, 2020).

Janet Woodcock, who then served as director of the agency’s Center for Drug Evaluation and Research (CDER), defended the FDA’s decision, saying the data supported the view that each dosage studied rapidly reduced the virus compared to placebo.

Including Eli Lilly’s most recent EUA, the FDA has so far authorized three neutralizing antibody treatments for COVID-19. The FDA granted an EUA for Regeneron’s COVID-19 antibody cocktail in November 2020 for mild-to-moderate COVID-19 patients at risk of progressing to severe illness or hospitalization (DID, Nov. 24, 2020).

Woodcock, now acting commissioner of the FDA, said last month that the U.S. has not seen full utilization of monoclonal antibody treatments although more than half a million doses have been distributed. The treatments, which are manufactured antibodies that mimic those made by the body in response to an infection, must be administered by IV, making treatment more of a logistical challenge for nonhospitalized patients.

Additionally, HHS has noted that healthcare providers and the public are not fully aware of the potential benefits and uses of monoclonal antibodies, an issue it has addressed by publicly promoting the drug and launching a website that helps patients find treatment locations. The department estimated in January that approximately 75 percent of the treatment courses it had allocated were unused at that point.

Eli Lilly said it will continue distributing bamlanivimab alone while also ramping up production of etesevimab to deliver up to 1 million doses by mid-2021. Currently, 100,000 doses of the drug are available, and an additional 150,000 will be supplied in the first quarter of 2021, the company said. — James Miessler