FDA re­quires Re­gen­eron, Lil­ly to mon­i­tor vari­ants as a con­di­tion of mAb EUAs

As part of an ef­fort to shore up pub­lic con­fi­dence in the FDA’s emer­gency use au­tho­riza­tion process­es, the agency on Mon­day re­leased ad­di­tion­al sci­en­tif­ic re­view doc­u­ments on Eli Lil­ly’s and Re­gen­eron’s mon­o­clon­al an­ti­bod­ies, which were au­tho­rized to treat mild to mod­er­ate Covid-19.

The new­ly re­leased let­ters of au­tho­riza­tion, which were up­dat­ed in late Feb­ru­ary, show that the agency is in­creas­ing­ly con­cerned about the abil­i­ty for cer­tain vari­ants, like B.1.351, the vari­ant first iden­ti­fied in South Africa, to evade the an­ti­body treat­ments.

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Cambridge, MA, USA