Sanofi, As­traZeneca mark big leap to­ward fil­ing of RSV drug in 2022, with safe­ty da­ta in hand to chal­lenge Synagis

The last big piece of the da­ta pack­age that Sanofi and As­traZeneca need­ed to file their RSV an­ti­body with the FDA is now in.

In a Phase II/III tri­al in­volv­ing ba­bies who were born preterm or had chron­ic lung dis­ease or con­gen­i­tal heart dis­ease, the part­ners said, nir­se­vimab showed a sim­i­lar safe­ty and tol­er­a­bil­i­ty pro­file com­pared to Synagis — the stan­dard and on­ly drug cur­rent­ly avail­able for the same group. They are eye­ing a fil­ing in the first half of 2022.

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