Sanofi, As­traZeneca clinch first OK for RSV an­ti­body — just as vac­cines line up at reg­u­la­tors

The EU has of­fi­cial­ly stamped its seal of ap­proval for nir­se­vimab, the an­ti­body joint­ly de­vel­oped by Sanofi and As­traZeneca to pre­vent RSV dis­ease in in­fants.

Bey­for­tus will be the first sin­gle-dose pro­tec­tive op­tion for new­borns and in­fants dur­ing their first RSV sea­son, the com­pa­nies not­ed. While a dif­fer­ent an­ti­body, Synagis, has been on the mar­ket for two decades, it on­ly cov­ers a sub­set of in­fants at high risk of se­vere dis­ease and it has to be ad­min­is­tered month­ly.

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