Lilly Ends U.S. Use of Single Covid-19 Antibody Drug Alone -- Update
By Peter Loftus
Eli Lilly & Co. has asked U.S. health regulators to revoke
the authorization for use of its Covid-19 antibody drug
bamlanivimab alone because it is less potent against certain
coronavirus variants circulating in the U.S.
Instead, Lilly said Friday it will focus on distributing a drug
cocktail containing bamlanivimab and a second antibody, named
etesevimab, that studies indicate neutralize more of the emerging
Covid-19 variants in the U.S. when given together than bamlanivimab
The Food and Drug Administration later Friday granted Lilly's
request and revoked its authorization of using bamlanivimab alone,
saying its benefits no longer outweighed its risks because of the
increase of variants that are resistant to the drug. The agency
said combination antibody therapies remain appropriate to use.
The drugmaker's request hints at the extent of the challenge
that new strains of the virus could pose to treatments and
vaccines. To stay ahead of any variants that could emerge able to
evade currently available shots, health authorities have been
racing to vaccinate as many people as possible.
Indianapolis-based Lilly said bamlanivimab alone should no
longer be administered in the U.S. because of the variant
challenge. The company said there weren't any new safety
"With the growing prevalence of variants in the U.S. that
bamlanivimab alone may not fully neutralize, and with sufficient
supply of etesevimab, we believe now is the right time to complete
our planned transition and focus on the administration of these two
neutralizing antibodies together," Lilly Chief Scientific Officer
Daniel Skovronsky said.
The variants that the drug cocktail can better neutralize
include two closely related strains, known as B.1.427 and B.1.429,
that currently account for about 50% of the virus in California and
more than 10% in some other states, the company said.
Antibody drugs are essentially clones of immune-system
antibodies that the body produces to fight the coronavirus.
Regeneron Pharmaceuticals Inc. also has developed a Covid-19
antibody treatment. They were intended to fill a gap in treatment
by helping patients early in the disease, and by potentially
preventing disease in people exposed to the virus.
Lilly raced to develop bamlanivimab last year, and the FDA
authorized it in November to treat mild to moderate Covid-19 in
adult and pediatric patients who are at high risk for worsening to
severe disease or hospitalization.
In February, the FDA authorized the combination of bamlanivimab
and etesevimab to treat mild to moderate Covid-19, after a study
showed the treatment reduced hospitalizations and deaths versus a
The U.S. government in March restricted distribution of Lilly's
bamlanivimab alone in California, Arizona and Nevada because of
concerns that variants were blunting its effectiveness. The federal
government subsequently stopped distribution of the single antibody
Lilly said medical providers shouldn't dispose of bamlanivimab
supply, but instead should order etesevimab to pair with it.
Lilly isn't requesting the withdrawal of bamlanivimab alone in
other countries but said the combination therapy is preferred.
Write to Peter Loftus at firstname.lastname@example.org
(END) Dow Jones Newswires
April 16, 2021 17:54 ET (21:54 GMT)
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