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Friday, June 27, 2025

US authorizes new antibody drug to fight omicron

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1229 days ago
20220214
This image provided by Eli Lilly and Company shows the packaging for bebtelovimab. U.S. health regulators on Friday, Feb 11, 2022, authorized the new antibody drug from Eli Lilly that specifically targets the omicron variant, a key step in restocking the nation's arsenal against the latest version of COVID-19. (Eli Lilly and Company via AP)

This image provided by Eli Lilly and Company shows the packaging for bebtelovimab. U.S. health regulators on Friday, Feb 11, 2022, authorized the new antibody drug from Eli Lilly that specifically targets the omicron variant, a key step in restocking the nation's arsenal against the latest version of COVID-19. (Eli Lilly and Company via AP)

By MATTHEW PER­RONE and RI­CAR­DO AL­SON­SO-ZAL­DIVAR-As­so­ci­at­ed Press

 

WASH­ING­TON (AP) — U.S. health reg­u­la­tors on Fri­day au­tho­rized a new an­ti­body drug that tar­gets the omi­cron vari­ant, a key step in re­stock­ing the na­tion’s ar­se­nal against the lat­est ver­sion of COVID-19.

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.

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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