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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