FDA Filing of Alzheimer’s Therapy Aducanumab Delayed to Late 2020, Biogen Says

FDA Filing of Alzheimer’s Therapy Aducanumab Delayed to Late 2020, Biogen Says
Biogen is pushing back the submission of aducanumab, its investigational treatment for Alzheimer's disease, to the U.S. Food and Drug Administration (FDA) to the third quarter of this year due to the COVID-19 pandemic, the company announced. “The COVID-19 pandemic has created a challenging situation for people and companies throughout the world, and Biogen personally felt the painful impact of this global crisis,” Michel Vounatsos, Biogen’s CEO, said in a company report. "Outside the U.S., we have had initial aducanumab discussions with regulators in Europe and Japan, although these interactions are still in the early stages." Although the company had originally anticipated filing the biologics license application with the FDA by early this year and has already started to submit parts of the application, Biogen now says it will complete the submission only after a meeting with the FDA, scheduled for the summer. "It's been difficult to predict the timing partly because [the BLA filing] has been an unusual process right from the beginning," Al Sandrock, Biogen’s head of research and development, said in a business update from Biogen. “Nothing has come up with the data that has changed our interpretation.” Meanwhile, the first patient has been dosed in the Phase 3 EMBARK clinical trial (NCT04241068), which is investigating re-dosing aducanumab in patients who participated in previous trials. Aducanumab, in development by Biogen and Eisai, is an investigational human monoclonal antibody that works by targeting the toxic clumps of amyloid beta, thought to be the underlying cause of Alzheimer’s. Aducanumab was investigated in ENGAGE (NCT02477800) and EMERGE (NCT02484547), two Phase 3 trials that evaluated two doses of aducanumab in people with
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