As­traZeneca and Sanofi sharp­en RSV pitch with new analy­ses, but how much weight will FDA give them?

As the next-gen RSV vac­cine and treat­ment race con­tin­ues to heat up, As­traZeneca and Sanofi are putting forth a new dataset they think will help their chances at the FDA — but it’s un­clear how per­sua­sive they might be.

In a “pre­spec­i­fied pooled analy­sis” of Phase IIb and Phase III da­ta, the two Big Phar­ma com­pa­nies said their RSV an­ti­body nir­se­vimab proved 79.5% ef­fec­tive at pre­vent­ing low­er res­pi­ra­to­ry tract in­fec­tions that need­ed med­ical at­ten­tion. On top of that, the analy­sis showed the an­ti­body was 77.3% ef­fec­tive at keep­ing healthy in­fants who re­ceived the op­ti­mized dose out of the hos­pi­tal af­ter five months — or for an en­tire RSV sea­son.

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