Af­ter an EU ap­proval, As­traZeneca and Sanofi's RSV an­ti­body seeks an FDA thumbs-up in Q3

The FDA is now re­view­ing As­traZeneca’s nir­se­vimab, a po­ten­tial an­ti­body drug de­signed in col­lab­o­ra­tion with Sanofi for res­pi­ra­to­ry syn­cy­tial virus (RSV) that won ap­proval in Eu­rope in late Oc­to­ber.

Cas­es of RSV have re­mained high across the US this win­ter, and the FDA will “ex­pe­dite its re­view,” ac­cord­ing to As­traZeneca, with a tar­get date for a de­ci­sion in the third quar­ter for nir­se­vimab. Nir­se­vimab earned a break­through ther­a­py des­ig­na­tion back in 2019.

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