FDA hands As­traZeneca-Am­gen broad ap­proval for asth­ma an­ti­body, clear­ing block­buster path

Af­ter last year’s Phase III re­sults, there was lit­tle ques­tion that the FDA would ap­prove Am­gen and As­traZeneca’s long-in­cu­bat­ing an­ti­body for asth­ma, bar­ring any man­u­fac­tur­ing de­lays or shock­ing sta­tis­ti­cal sna­fus. The key ques­tion was how many asth­ma pa­tients would be ap­proved by reg­u­la­tors.

The an­swer was a lot, it turned out. De­spite mixed da­ta in some set­tings, the FDA on Fri­day OK’d teze­pelum­ab for vir­tu­al­ly any pa­tient 12 years or old­er with se­vere asth­ma.

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