In a dizzying reversal, Biogen announced today that it would seek approval from the U.S. Food and Drug Administration (FDA) to begin marketing its experimental Alzheimer’s drug that it had abruptly killed nine months ago.
In March, saying that the drug had failed a “futility analysis,” the company stunned the Alzheimer’s community by abruptly ending its phase three studies.
The company said that its new announcement was based on further data analysis that showed that patients who received aducanumab “experienced significant benefits” in memory and general cognition.
“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,” the company said.
Aducanumab targets the build-up of amyloid in the brain, which has long been suspected as a cause of Alzheimer’s. If approved by the FDA, aducanumab would be the first treatment to demonstrate that removing amyloid from the brain impacts Alzheimer’s.
“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s,” said Michel Vounatsos, Chief Executive Officer at Biogen.
He added that the company is “hopeful about the prospects of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease.”
In an earnings webcast this morning, Biogen’s Vounatsos said it would work “as quickly as possible” to “redose eligible patients” who were part of the phase three trials that were cancelled in March.
Jeff Borghoff, a Being Patient advisor who was part of the aducanumab trial for more than three years, said he was elated by the news, but he has many questions.
“The last nine months have been such an emotional roller coaster as we tried to understand why the aducanumab trials were cancelled when so many of us felt the drug was working,” Borghoff said.
Biogen noted that the reversal is based on a new analysis of a larger dataset from the Phase 3 clinical studies that included additional data that became available.
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Dr. Anton Porsteinsson, a principal investigator and professor of psychiatry, neurology and neuroscience and director of the University of Rochester Alzheimer’s Disease Care, Research and Education Program, said the Biogen results “provided new hope for the medical community, the patients and their families.”
In its announcement, Biogen said that patients who received a “high dose” of the aducanumab did best in the trials. Patients received either a high dose, a low dose or a placebo.
The Alzheimer’s Association welcomed the development, saying that “no stone can be left unturned” in the search for a treatment or cure.
“We must advance all potential treatment avenues and also explore methods for combining these approaches,” the Association said. “Alzheimer’s and other dementias are complex and their effective treatment will likely also be a complex—but achievable—task.”
In March, Biogen left trial participants, researchers and investors reeling when it halted its two Stage 3 clinical trials that had previously reported positive results.
Aducanumab had previously hailed as the hope on which an Alzheimer’s cure was pinned.
Today’s announcement begins to restore that hope but there are many questions that remain. Being Patient will be providing additional analysis about the new announcement in the days to come.