FDA ad­comm votes unan­i­mous­ly in fa­vor of As­traZeneca's pre­ven­tive mAb for RSV in in­fants

The FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee vot­ed 21-0 in fa­vor of the ben­e­fit-risk pro­file of As­traZeneca’s nir­se­vimab, a mon­o­clon­al an­ti­body in­tend­ed to pre­vent res­pi­ra­to­ry syn­cy­tial virus (RSV) in in­fants born dur­ing or en­ter­ing their first RSV sea­son.

Com­mit­tee mem­bers ex­plained how RSV can lead to sig­nif­i­cant ill­ness, hos­pi­tal­iza­tion and deaths for young chil­dren, cre­at­ing a clear need for an­oth­er drug, and the tri­al da­ta show the prod­uct will pre­vent a sig­nif­i­cant num­ber of RSV cas­es.

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