FDA ad­comm of­fers thumbs up on As­traZeneca's 2-in-1 asth­ma in­haler — but on­ly for adults

As­traZeneca’s ex­per­i­men­tal asth­ma drug cruised through an FDA ad­vi­so­ry com­mit­tee, as the pan­el of ex­ter­nal ex­perts of­fered an over­whelm­ing thumbs up for its use in adults.

But when it came to ado­les­cents and kids, the ad­comm was less sure.

The mixed votes could cast a shad­ow on the as­pi­ra­tions at As­traZeneca, which had pro­posed a broad la­bel in its NDA fil­ing for PT027 that cov­ers pa­tients 4 years or old­er. In con­ven­ing the ad­comm, the FDA had not­ed that the da­ta on pe­di­atric pa­tients was a big fo­cus.

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