The Food and Drug Administration said it cleared the Eli
Lilly drug for adults and adolescent patients with mild-to-moderate cases of
COVID-19. Lilly announced work on the treatment late last year after testing
revealed that its previous antibody therapy was ineffective against the
dominant omicron variant.
The Biden administration has purchased 600,000 doses before
the authorization and will begin shipping initial supplies to state health
authorities for distribution.
It’s “an important step in meeting the need for more tools
to treat patients as new variants of the virus continue to emerge,” said Dr.
Patricia Cavazzoni, FDA’s drug center director.
The FDA announcement comes after the two leading monoclonal
antibody treatments in the U.S. turned out to be ineffective against omicron.
Data indicate the Lilly drug also works against the emerging BA.2 mutation of
omicron.
Lilly said the contract for its new drug — bebtelovimab,
pronounced “beb-teh-LO-vi-mab” — is worth at least $720 million.
Laboratory-made monoclonal antibodies stand in for the human
body’s immune system by acting to block an invading virus. Delivered by IV or
by injection, the medicines are meant to be used early in an infection.
But late last month the FDA revoked its emergency use
authorization for Regeneron’s antibody drug, along with Lilly’s. The two medications
had been the the backbone of antibody treatment, and doctors were hard pressed
to come up with fallbacks when they didn’t work against omicron.
Alternate therapies, including antiviral pills from Pfizer
and Merck, have been in short supply. An antibody drug from GlaxoSmithKline
that remains effective against omicron is also scarce.
Scientists say COVID-19 treatments like monoclonal
antibodies are not a substitute for vaccination.
Under the U.S. contract with Lilly, the government will
receive about 300,000 treatment courses of the new antibody drug in February
and another 300,000 in March.
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