UK signs off on Sanofi, As­traZeneca's RSV an­ti­body four days af­ter Eu­rope

First, it was the CHMP. Then the Eu­ro­pean Com­mis­sion, and as of Wednes­day, the UK’s MHRA (but still no FDA).

The UK’s Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency ap­proved nir­se­vimab, Sanofi and As­traZeneca’s col­lab­o­ra­tive an­ti­body for RSV Wednes­day. The ap­proval comes less than one week af­ter the an­ti­body, brand name Bey­for­tus, won ap­proval for use in the EU.

It will be the first sin­gle-dose op­tion for all new­borns and in­fants dur­ing their first RSV sea­son. A dif­fer­ent an­ti­body, Synagis, has been on the mar­ket for two decades, yet it on­ly cov­ers a cer­tain sub­set of in­fants who are at risk for se­vere dis­ease.

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