Food and Drug Administration

On Friday, November 6th, 2020 the Federal Drug Administration (FDA) held an advisory meeting on the approval of Biogen’s Alzheimer’s medication Aducanumab, see Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement.  The outcome of the FDA advisory meeting is detailed here: UPDATE ON FDA ADVISORY COMMITTEE’S MEETING ON ADUCANUMAB IN ALZHEIMER’S DISEASE.

It was an honor to be the first speaker at the Open Public Hearing (OPH) and address the FDA and scientific advisors with my full statement below.  I was very encouraged to hear so many people tell their personal stories of how they believe Aducanumab has made a difference in their lives and so disappointing to the advisors all but unanimously vote against Aducanumab’s approval at this time.  With this said I’m encouraged that Biogen will continue with Aducanumab clinical trials.

My Full Statement

My name is Jeff Borghoff and I represent the Alzheimer’s Association and my clinical trial center Advanced Memory Research Institute of NJ.

Thank you for allowing me to speak to you today about my personal experience with the Biogen Aducanumab clinical trial. This experience, however, is not limited to me, it extends to my wife, my three children, and all who know and love me.

When I was first diagnosed with Alzheimer’s disease In 2016 at the age of 51, I quickly resolved myself to the prognosis of the disease and immediately took steps to confront this monster that would eventually take my life and enrolled in the Aducanumab trial.

I understand that Biogen needed to make a decision to halt the trial based on a futility analysis. However, it is difficult to express my overwhelming sense of gratitude that in October of 2019, the same year, we were notified the trial was going to be reopened for re-enrollment as the EMBARK study with the goal to move forward to FDA approval.

During my time in the trial, my cognition and other neurological functions have not significantly declined, for that matter, we believe there has been some improvement.

In October of this year, I completed my 9th EMBARK infusion and I am still doing and testing well without any known side effects.

It’s important for this committee to understand that my family and I know Aducanumab is not a cure for Alzheimer’s disease, we understand that it is meant to slow the decline of neurological functions and that is our hope.

My wife and family often say that we can live with the damage that has been done to my brain from Alzheimer’s as long as I can live longer.

In many cases with a diagnosis of younger-onset Alzheimer’s disease, the person is faced with just a few years. I am coming up on my 5th year with my 3 kids graduating from University and celebrating my middle daughter’s wedding.

These are major quality of life milestones, and bucket list items we thought we would miss. We believe that grandchildren will be the next milestone bucket list item in no small part to the much needed Aducanumab medication.

My wife Kim has said,

My daughter Aubreigh stated,

My daughter Erin said,

My request is that you allow the Aducanumab clinical trial to continue with the hope of its approval. Thank you for your time and consideration.