As­traZeneca, Am­gen roll up a 'break­through' at the FDA in hot pur­suit of a po­ten­tial game chang­er in asth­ma

By this point, the nov­el­ty of the FDA’s break­through ther­a­py des­ig­na­tion has large­ly been worn away by a drum­beat of an­nounce­ments for new ad­di­tions to the pro­gram. But As­traZeneca and Am­gen just land­ed one that de­serves a clos­er look.

Reg­u­la­tors have hand­ed the big league part­ners VIP sta­tus for a se­vere asth­ma drug called teze­pelum­ab. As al­ways, BTD gives them ready ac­cess to FDA in­sid­ers who are now pledged to help push this through to a speedy con­clu­sion. And we know now that that promise is worth some­thing.

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