Biogen Inc. (BIIB) - Get Report shares surged higher Wednesday after the drugmaker asked the U.S. Food & Drug Administration for a priority review of its key treatment for Alzheimer's disease, just over a year after abandoning late-stage trials.
Biogen said the application for approval of aducanumab, a treatment for patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia, gives the FDA 60 days to either accept or review, after which it will make a determination on its potential approval.
Last year, Biogen said a phase III trial of aducanumab, which it was conducting alongside Japan's Eisai Co. Ltd. (ESALY) was abandoned after deeming the drug was unlikely to be successful, but noted safety issues were not the basis for the cancellation. Bigoen then announced a reversal of that decision in October 2019, after new analysis of a larger data set indicated that the drug did indeed have success, when administered in higher doses.
“Alzheimer’s disease remains one of the greatest public health challenges of our time. It robs memories, independence and eventually the ability to perform basic tasks from the people we love,” said CEO Michel Vounatsos. “The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease. We are committed to driving progress for the Alzheimer’s disease community and look forward to the FDA’s review of our filing.”
Biogen shares were marked 4.75% higher in early trading Wednesday to change hands at $281.15 each, a move that would trim the stock's year-to-date decline to around 4%.
Alzheimer's disease, a progressive brain disorder, affects more than 50 million people around the world. To date, no drug has been found to address the disease, which can accelerate into dementia and other more serious cognitive conditions.
Earlier this year, Eli Lilly & Co. (LLY) - Get Report said trial of solanezumab, a drug used to treat patients with, or who are at risk for, dominantly inherited Alzheimer's disease failed to meet the primary endpoint set for the multi-year study, which was conducted with Switzerland's Roche.
Eli Lilly said secondary endpoint studies are ongoing and noted that fuller results will be presented to the Advances in Alzheimer's and Parkinson's Therapies focus meeting in April.