As­traZeneca, Avil­lion de­tail the piv­otal com­bo asth­ma da­ta they're tak­ing to the FDA

Months af­ter tout­ing some fuzzy top-line read­outs, As­traZeneca and its biotech part­ner Avil­lion to­day are de­tail­ing the da­ta they’re tak­ing to reg­u­la­tors for its asth­ma drug.

The can­di­date PT027 is an in­haled, fixed-dose res­cue med­ica­tion con­tain­ing al­buterol, a com­mon asth­ma treat­ment con­tain­ing short-act­ing be­ta2-ag­o­nist (SA­BA), and budes­onide — an in­haled and com­mon­ly used cor­ti­cos­teroid.

For their Phase III tri­al, dubbed MAN­DALA, the pri­ma­ry end­point was the time to first se­vere asth­ma ex­ac­er­ba­tion dur­ing the treat­ment pe­ri­od. The da­ta showed that com­pared with al­buterol res­cue alone, PT027 re­duced the risk of a se­vere ex­ac­er­ba­tion by 27% (p<0.001) in adults and ado­les­cents. In the tri­al, pa­tients were ran­dom­ized to re­ceive PT027 or al­buterol res­cue, on top of their usu­al­ly pre­scribed main­te­nance ICS, with or with­out ad­di­tion­al con­troller med­i­cines.

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