Today, the public gets a preview of FDA staff recommendations and drugmaker presentations in advance of this Friday’s advisory committee meeting to discuss Biogen’s licensing application for its experiential Alzheimer’s drug aducanumab. A recommendation vote will take place during the November 6 meeting, and an approval decision is expected be finalized by March, 2021.
Biogen’s experimental Alzheimer’s drug received a boost from government regulators today who said the biopharmaceutical company had provided “substantial evidence of the effectiveness of aducanumab.”
Leading up to a highly anticipated meeting of the Peripheral and Central Nervous System Drugs Advisory Committee meeting, scheduled for this Friday November 6, FDA staff conclusions were made public today in a large and highly technical data drop. Among the materials released today were the Biogen presentations before the Advisory Committee and FDA staff recommendations.
One scheduled presenter, Anton Porsteinsson, a professor of psychiatry, neurology, neuroscience and medicine at the University of Rochester, School of Medicine and Dentistry, will provide a perspective from clinicians who hosted aducanumab trials.
“Aducanumab clearly impacts underlying disease pathology, preserves cognitive and functional abilities and reduces behavioral decline,” Porsteinsson said in a statement.
Dr. Porsteinsson, who also directs the Alzheimer’s Disease Care, Research and Education Program at the University of Rochester, will tell advisory committee members that “it’s clear that treatment with aducanumab can provide a real, genuine, palpable and noticeable effect on the lives of patients with Early Symptomatic Alzheimer’s disease.”
“I look forward to having aducanumab as a treatment for my patients,” he said.
In August, the FDA set the date for this week’s advisory committee hearing and said it would decide whether to approve aducanumab no later that March 7, 2021.
If approved, aducanumab would become the first drug proven to slow the cognitive decline associated with Alzheimer’s disease. In announcing its decision to move forward, the FDA said that it would grant priority review to the Biogen application and added that it would try to decide on the application before the March target date.
Aducanumab’s path has been quite twisted. Initially introduced in early stage trials in 2016, aducanumab entered its Phase 3 trials with high hopes for success. But in March 2019, Biogen and Eisai stunned the Alzheimer’s community when they abruptly halted the end of the drug’s development after aducanumab failed a “futility analysis.”
If approved, aducanumab would become the
first drug proven to slow the cognitive decline
associated with Alzheimer’s disease.
The companies then reversed their stance in October 2019, saying that late-arriving data had actually shown improvements for people living with mild cognitive impairment or very early Alzheimer’s. And in December 2019, at a packed conference in San Diego, Biogen said that patients who received aducanumab experienced significant slowing of decline on measures of cognition and functions such as memory, orientation and language.
Biogen and Eisai officially sought FDA review of aducanumab in July 2020, submitting an application of more than 2.5 million pages.
This Friday’s advisory committee meeting will hear from Biogen scientists, FDA staff and several people living with Alzheimer’s.
Geri Taylor, who was diagnosed with mild cognitive impairment eight years ago, has been a long-time participant in the various aducanumab trials. She and her husband Jim are scheduled to urge the advisory committee to approve the drug.
“We believe that even if only some individuals respond to treatment, aducanumab would be a tremendous ray of hope for those who today, with no meaningful disease modifying therapy, often live difficult and sometimes desperate lives,” the couple said in a statement that is scheduled to be delivered on Friday.
Another Alzheimer’s advocate, Pam Montana, echoed the theme of hope in her prepared comments. “It’s time for those of us living with Alzheimer’s to hear some good news,” she writes. “We need hope that there will one day be a cure. We need hope that there will be a drug treatment that can slow down the progression.”
“We need hope that the 5.8 million people living with Alzheimer’s have faith that drug trials can and will make a difference for them and their family.”
In a lengthy letter to the FDA advisory committee, the Alzheimer’s Association wrote that “the publicly released data justifies approval” of aducanumab.
According to the Alzheimer’s Association, the alternative would be yet another large trial of the drug that could take up to four years.
“A four-year delay is too long to wait for millions of Americans facing a progressive, fatal disease,” Joanne Pike, the Association’s Chief Strategy Officer, wrote. “A four-year delay is too long to wait for millions of American caregivers.”
The Advisory Committee meeting will be accessible to the public via a free webcast. It is scheduled to be completed by 4 p.m. on Friday with a recommendation vote.