Ahead of FDA, EMA gives thumbs-up to As­traZeneca, Sanofi's RSV an­ti­body for in­fants and new­borns

The part­ner­ship be­tween As­traZeneca and Sanofi paid off on Fri­day.

The two Eu­ro­pean Big Phar­mas put out word that their joint­ly-de­vel­oped an­ti­body Bey­for­tus (nir­se­vimab) was giv­en a pos­i­tive mar­ket­ing au­tho­riza­tion rec­om­men­da­tion by the EMA’s CHMP to pre­vent RSV low­er res­pi­ra­to­ry tract dis­ease in both new­borns and in­fants. The ap­proval is the first of its kind for in­fants and new­borns.

RSV has been known as one of the more preva­lent caus­es of in­fant death and was the lead­ing cause of in­fant hos­pi­tal­iza­tion in the US and Eu­rope for a time in the late 1980s.

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