Aducanumab Granted FDA Fast Track Designation and Recent Interim Analysis from PRIME Consistent with Results Previously Reported

Today, Biogen reported that Aducanumab was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA’s Fast Track program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s disease.

In a recently completed interim analysis from PRIME, efficacy and safety data were consistent with results previously reported. These data support the design of the ongoing Phase 3 ENGAGE and EMERGE studies. Biogen plans to share detailed information about these results at upcoming medical meetings.