Am­gen, As­traZeneca bol­ster their case for break­through asth­ma pro­gram as FDA con­sid­ers tak­ing up a re­view

Just a few days af­ter sub­mit­ting a BLA for their high­ly-tout­ed asth­ma pro­gram, Am­gen and As­traZeneca re­leased new da­ta they hope will con­tin­ue to strength­en their FDA pitch.

The com­pa­nies re­leased fur­ther de­tailed Phase III re­sults for teze­pelum­ab ear­ly Thurs­day morn­ing, and pub­lished the full dataset in the New Eng­land Jour­nal of Med­i­cine. Teze­pelum­ab plus stan­dard of care “demon­strat­ed su­pe­ri­or­i­ty” across the pri­ma­ry and all key sec­ondary end­points com­pared to the stan­dard of care alone, they said.

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