Biogen to file for US approval of previously failed Alzheimer's candidate aducanumab

US biotech major Biogen (Nasdaq: BIIB) saw its shares rocket more than 41% to $315.74 in pre-market trading, after, along with partner Eisai (TYO: 4523), today announced that, following consulting with the US Food and Drug Administration, Biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer’s disease (AD), which has previously seen disappointing clinical results.

Biogen stock had lost 25.7% year to date through Monday, much due to the failure of its Alzheimer’s program.

The Phase III EMERGE Study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in the Phase III ENGAGE Study who received sufficient exposure to high dose aducanumab support the findings from EMERGE. Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. Patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.