Biogen Shocks the Medical Community With Reversal on Alzheimer's Drug

Grant Boone
October 23, 2019

Biogen Inc. on Tuesday made a surprising reversal on its Alzheimer's treatment with plans now to seek USA regulatory approval, after data from more patients in two discontinued studies showed that the drug improved cognition at high doses.

The reversal: In March, a "futility analysis" deemed the drug a no-go.

"It's a tricky question" whether the results are truly meaningful for patients until more details are known, said Dr Ronald Petersen, a Mayo Clinic dementia specialist who consulted for Biogen on the studies. Results for some patients in another study support those findings, as well. Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. It said it was continuing to speak to regulatory authorities in other markets, including Europe.

Credit Suisse analyst Evan Seigerman said the agency was under no obligation to approve the drug even if it gave its blessing to the initial filing for approval.

Based on discussions with the FDA, Biogen said it plans to submit a marketing application for aducanumab in early 2020.

The Company aims to offer access to aducanumab to eligible patients previously enrolled in the Phase 3 studies, the long-term extension study for the Phase 1b PRIME study, and the EVOLVE safety study.

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"This large dataset represents the first time a Phase 3 study has demonstrated that clearance of aggregated amyloid beta can reduce the clinical decline of Alzheimer's disease, providing new hope for the medical community, the patients, and their families", said Dr. Anton Porsteinsson, William B. and Sheila Konar Professor of Psychiatry, Neurology and Neuroscience, director of the University of Rochester Alzheimer's Disease Care, Research and Education Program (AD-CARE), and principal investigator. The hypothesis has been the driving force behind Alzheimer's research for more than 20 years. But no drug exists as of now that can slow down the progression of the disease, let alone cure it. In 2013, Pfizer scrapped another antibody, bapineuzumab, when it didn't surpass placebo effects in another Phase 3 trial. Years of clinical trial failures had suggested drugs created to clear these toxic protein accumulations were not resulting in meaningful clinical improvements for patients with moderate to severe Alzheimer's.

The death of aducanumab back in March widely signaled the broader failure of treatments created to target amyloid-beta plaques, the toxic protein aggregations commonly thought to be the cause of Alzheimer's-related neurodegeneration.

Johnson & Johnson's BACE inhibitor atabecestat, created to slow cognitive decline in people at risk for Alzheimer's, was also scrapped in May 2018 when liver enzymes spiked in study participants.

If the drug is approved by the FDA, it would be a landmark step toward finding a treatment that can alter the course of the most common form of dementia rather than just treat symptoms. Alzheimer's makes up 60-70% of an estimated 50 million cases of dementia globally.

In the release, BIIB said that it plans on pursuing regulatory approval for aducanumab.

The decision to file is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019 following a futility analysis. "We need to see the data presented to better understand the full implications", Reiman told MedPage Today.

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