EMA: On­go­ing study da­ta of Cell­tri­on’s mAb enough to al­low its use in some Covid-19 pa­tients

The Eu­ro­pean Med­i­cines Agency added an­oth­er mon­o­clon­al an­ti­body to the con­ti­nent’s Covid-19 ther­a­peu­tics ar­se­nal on Fri­day, con­clud­ing that Cell­tri­on’s reg­dan­vimab can be used as a treat­ment for adults with Covid-19 who do not re­quire sup­ple­men­tal oxy­gen and who are at high risk of pro­gress­ing to se­vere Covid-19.

The EMA said its rec­om­men­da­tion is based on a re­view of da­ta from the first part of an on­go­ing study show­ing reg­dan­vimab may low­er the rate of hos­pi­tal­iza­tions in adult out­pa­tients with Covid-19 symp­toms de­scribed as mild to mod­er­ate who do not need sup­ple­men­tal oxy­gen.

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