Global Statistics

All countries
137,265,460
Confirmed
Updated on April 12, 2021 11:33 pm
All countries
110,435,455
Recovered
Updated on April 12, 2021 11:33 pm
All countries
2,958,863
Deaths
Updated on April 12, 2021 11:33 pm
Monday, April 12, 2021

Global Statistics

All countries
137,265,460
Confirmed
Updated on April 12, 2021 11:33 pm
All countries
110,435,455
Recovered
Updated on April 12, 2021 11:33 pm
All countries
2,958,863
Deaths
Updated on April 12, 2021 11:33 pm
Molderizer and Safe Shield

FDA spells out how the Covid-19 variants impact the effectiveness of Regeneron, Eli Lilly mAb treatments – Endpoints News

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The FDA on Thurs­day af­ter­noon up­dat­ed its three fact sheets on the mon­o­clon­al an­ti­body treat­ments from Eli Lil­ly and Re­gen­eron, of­fer­ing new da­ta on the sus­cep­ti­bil­i­ty of the SARS-CoV-2 vari­ants orig­i­nat­ing in the UK, Brazil, South Africa, Cal­i­for­nia and New York to each of the mAb ther­a­pies.

“Some vari­ants can cause re­sis­tance to one or more of the mAb ther­a­pies au­tho­rized to treat COVID-19,” FDA said. “Health care providers should re­view the au­tho­rized fact sheets for in­for­ma­tion on the use of the au­tho­rized mAb ther­a­pies against cur­rent­ly cir­cu­lat­ing vi­ral vari­ants.”

For Lil­ly’s bam­lanivimab alone, which is no longer be­ing dis­trib­uted by the US gov­ern­ment in Cal­i­for­nia, Neva­da and Ari­zona be­cause of the vari­ant orig­i­nat­ing in Cal­i­for­nia, the FDA not­ed in its re­vised fact sheet ma­jor re­duc­tions in sus­cep­ti­bil­i­ty for all of the vari­ants stud­ied, ex­cept for the one orig­i­nat­ing in the UK. Al­most 800,000 cours­es of bam­lanivimab have now been dis­trib­uted across the US, in­clud­ing more than 100,000 cours­es to Cal­i­for­nia, Neva­da and Ari­zona.

But for Lil­ly’s com­bi­na­tion ther­a­py of bam­lanivimab and ete­se­vimab, the up­dat­ed fact sheet showed the treat­ment fared bet­ter against all of the vari­ants than bam­lanivimab alone. A Lil­ly spokesper­son said in a state­ment: “It has al­ways been our view that ad­di­tion­al an­ti­bod­ies from Lil­ly and oth­ers will need to be de­vel­oped to ad­dress the evo­lu­tion of the virus, in­clud­ing emerg­ing vari­ants that can dif­fer by coun­try or even by state. In fact, this is what drove our work on bam­lanivimab and ete­se­vimab to­geth­er and con­tin­ues to un­der­pin our strat­e­gy mov­ing for­ward.”

And Re­gen­eron’s mAb com­bi­na­tion of casiriv­imab with imde­vimab showed the least re­duc­tion in sus­cep­ti­bil­i­ty against the vari­ants, ac­cord­ing to its up­dat­ed fact sheet. Through Feb. 2, the US says it’s al­lo­cat­ed 148,022 dos­es of the Re­gen­eron mAb cock­tail.

“FDA is re­quired to reg­u­lar­ly re­view the cir­cum­stances and ap­pro­pri­ate­ness of an EUA, and the agency con­tin­ues to re­view emerg­ing sci­en­tif­ic in­for­ma­tion as­so­ci­at­ed with the emer­gency us­es for the au­tho­rized mAb prod­ucts, in­clud­ing in­for­ma­tion on vi­ral vari­ants,” the agency said in a state­ment. “FDA is com­mit­ted to pro­vid­ing up­dat­ed in­for­ma­tion on vari­ants and their po­ten­tial im­pact on the au­tho­rized mAb ther­a­pies as new in­for­ma­tion be­comes avail­able.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.



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