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Eli Lilly and 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-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 combo treatment is the second COVID-19 antibody therapy from the Indianapolis-based drugmaker to gain an emergency authorization from the FDA. In November, the agency cleared bamlanivimab, one of the two antibodies used in the cocktail, for use in non-hospitalized, high-risk patients with mild-to-moderate symptoms of COVID-19.
Lilly’s shares rose 1.2%, to $204.21 each, on Wednesday morning.
Bamlanivimab, developed with AbCellera Biologics Inc., mimics the immune system’s virus-fighting powers. Regeneron Pharmaceuticals Inc. also gained FDA authorization for a product combining two antibodies last year. Former President Donald Trump received Regeneron’s drug after contracting COVID-19.
Many drugmakers, from AstraZeneca to Bristol Myers Squibb, are developing products to compete in the increasingly crowded field.
Lilly’s 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. Patients must get the infusion as soon as possible after a positive COVID-19 test or within 10 days of symptom onset.
With additional manufacturing help from Amgen Inc., Lilly said it will produce up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021. The companies have already made 100,000 doses of etesevimab, and another 150,000 doses will be made available throughout the first quarter.
In late January, Lilly reported results from a late-stage trial showing that a combination of bamlanivimab and etesevimab cut the chances of hospitalizations and deaths 70% in high-risk patients.
Lilly’s study of the cocktail found no difference between the monotherapy and combination in such outcomes.
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.
On Tuesday, the FDA authorized Lilly’s monotherapy to be given in 16 minutes, a reduction from the previous requirement of an hour-long infusion. The new combination therapy can be given in 21 minutes.
The shift in regulatory guidance was made in response to feedback from nurses and doctors, and is “aimed at reducing the burden on the health care system,” according to Lilly.
U.S. health officials, including the top infectious disease expert, Dr. Anthony Fauci, have said the treatments could be less effective against new fast-spreading virus variants that first surfaced in South Africa and Brazil.
Etesevimab was licensed by Lilly from Junshi Biosciences, which developed it with the 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.
“With the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world,” Lilly Chief Scientific Officer Dan Skovronsky said in a statement.
Skovronsky previously said he expects use of bamlanivimab to shift toward the combination around the middle of this year.
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