FDA clears a Phase III path for Bio­gen’s BACE drug for Alzheimer’s

Bio­gen has tak­en an­oth­er step for­ward in prep­ping a Phase III pro­gram for its BACE drug for Alzheimer’s, with its part­ner Ei­sai not­ing that the FDA has signed off on the late-stage pro­gram. The plan now is to get reg­u­la­tors in Japan and Eu­rope to of­fer a green light as well and run it as a glob­al reg­is­tra­tion study.

E2609 was one of two drugs that Bio­gen part­nered on with Ei­sai back in the spring of 2014. BAN2401 was al­so in­clud­ed as Bio­gen trad­ed off de­vel­op­ment rights on ad­u­canum­ab (BI­IB037) and an an­ti-tau ap­proach. Now in­ves­ti­ga­tors will take the high 50 mg dose of E2609 in­to Phase III stud­ies.

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