In a bat­tered field, As­traZeneca's lu­pus drug clears piv­otal study — but can they get it ap­proved now?

A year af­ter As­traZeneca ad­mit­ted de­feat in a late-stage study test­ing its lu­pus drug an­i­frol­um­ab, the British drug­mak­er has cleared their sec­ond piv­otal tri­al, hit­ting the pri­ma­ry end­point and leav­ing their re­search team hope­ful that they have enough da­ta in hand to get an ap­proval.

Last year, an­i­frol­um­ab failed to meet the main goal of di­min­ish­ing dis­ease ac­tiv­i­ty in the 460-pa­tient TULIP 1 study, a 52-week tri­al that test­ed two dos­es of the drug ver­sus a place­bo. But in the 373-pa­tient TULIP II study, the high­er dose (300 mg) was com­pared to pa­tients giv­en a place­bo — and the study met the main goal of re­duc­ing dis­ease sever­i­ty.

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