FDA Delays Decision for Biogen's Alzheimer's Drug Until June

BioSpace reports that the U.S. Food and Drug Administration (FDA) has extended the review period for Biogen and Eisai's Biologic License Application (BLA) for aducanumab for Alzheimer's disease from March 7 to June 7. Biogen and Eisai announced near the end of 2019's first quarter that they were discontinuing the global Phase III clinical trials ENGAGE and EMERGE of aducanumab in persons with mild cognitive impairment for Alzheimer's and mild Alzheimer's dementia, as well as the EVOLVE Phase II trial and the long-term extension PRIME Phase Ib trial. But in October of that year, the companies announced plans to pursue regulatory approval for the drug, as the Phase III EMERGE trial met its primary endpoint, indicating significant decrease in clinical decline. This was apparently enough to file for a BLA, which Biogen intended to do the second quarter of 2020. In April 2020, the partners announced that while Biogen begun to submit parts of the BLA, they did not expect to complete it until the third quarter of 2021. This past November, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee criticized the submission, voting repeatedly against it. The most recent delay is apparently related to the FDA requesting additional analyses and clinical data, which Biogen has complied with. "We are committed to working with the FDA as it completes its review of the aducanumab application," said Biogen CEO Michel Vounatsos.