WASHINGTON — Eli Lilly & Co.’s combination antibody drug for COVID-19 was cleared for emergency use by U.S. regulators, providing doctors with a treatment option that is expected to be better able to combat new coronavirus mutations.
The Food and Drug Administration authorized the treatment for use in COVID-19-positive adults and children 12 and older who are at high risk of developing severe forms of the disease or progressing to the hospital, according to a fact sheet posted Tuesday by the agency.
The treatment is the second antibody therapy from the Indianapolis-based drugmaker to gain an emergency authorization from the FDA. In November, the agency cleared bamlanivimab for use in nonhospitalized, high-risk patients with mild-to-moderate symptoms of COVID-19.
Bamlanivimab, developed with AbCellera Biologics Inc., mimics the immune system’s virus-fighting powers. Regeneron Pharmaceuticals Inc. also gained FDA authorization for a similar product combining two antibodies last year.
The newly authorized combination includes a 700 milligram dose of bamlanivimab, and a 1,400 milligram dose of another antibody called etesevimab. The tandem will be supplied in separate single-dose vials, but administered together using a single infusion bag, according to the FDA.
In late January, Indianapolis-based Lilly said a combination of bamlanivimab and etesevimab cut the chances of hospitalizations and deaths by 70% in high-risk patients.
Despite being touted as potential bridges to a vaccine, uptake of the complicated antibody medicines has been slow. Health care providers have struggled to put in place the proper infusion clinics necessary to administer them, doctors have been reluctant to prescribe them based on limited late-stage efficacy data, and patients have had difficulties figuring out where to get them.
U.S. health officials, including the top infectious disease expert, Anthony Fauci, have also said that the treatments could be less effective against new fast-spreading virus variants that first surfaced in South Africa and Brazil.
Etesevimab was licensed by Eli Lilly from Junshi Biosciences, which developed it with Institute of Microbiology, Chinese Academy of Science. The U.S. drugmaker decided to pursue a combination of bamlanivimab and etesevimab in hopes it would prove more robust against variants.
Lilly’s study of the cocktail found no difference between the monotherapy and combination in outcomes like hospitalization and deaths.
Lilly Chief Scientific Officer Dan Skovronsky said in an interview that he expects use of bamlanivimab will shift toward the combination around the middle of this year.
.png?w=600)
