As­traZeneca sets stage for mar­ket­ing ap­pli­ca­tion with promis­ing piv­otal lu­pus drug da­ta

Af­ter fum­bling in its first late-stage lu­pus study, As­traZeneca dis­closed that a sec­ond piv­otal tri­al test­ing its ex­per­i­men­tal drug, an­i­frol­um­ab, had met the main goal, in Au­gust. Ear­li­er this week, the British drug­mak­er broke out the num­bers from its suc­cess­ful study.

Last year, an­i­frol­um­ab failed to meet the main goal of di­min­ish­ing dis­ease ac­tiv­i­ty in the 460-pa­tient TULIP I 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 — pa­tients in both arms were on base­line stan­dard care.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.