A ma­jor reshuf­fling at the FDA opened the road for Bio­gen’s Alzheimer’s drug. Can it cross the fin­ish line?

All things con­sid­ered, Bio­gen has walked a rel­a­tive­ly easy road to next Mon­day’s ap­proval de­ci­sion for its con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab.

Af­ter flunk­ing a Phase III tri­al, the com­pa­ny of­fi­cial­ly pulled the plug on the drug a lit­tle more than two years ago, dash­ing any hopes that an­oth­er tri­al might prove of­fer proof that this po­ten­tial drug ac­tu­al­ly worked.

But then in Oc­to­ber 2019, Bio­gen pulled a sur­pris­ing about-face, de­cid­ing to re­vive the drug while not­ing, “Fol­low­ing dis­cus­sions with the FDA, Bio­gen plans to sub­mit a reg­u­la­to­ry fil­ing in ear­ly 2020.” The com­pa­ny now claimed that the orig­i­nal “fu­til­i­ty analy­sis was in­cor­rect,” and that “ad­u­canum­ab re­duced clin­i­cal de­cline in pa­tients with ear­ly Alzheimer’s dis­ease.”

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