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A Case for FDA Approval: Biogen’s Aducanumab - First-Ever Drug to Slow Progression of Alzheimer’s

Updated: Mar 10



Image Credit: Robina Weermeijer

Time kills deals, as the saying goes. And the biggest deal on the Alzheimer’s front—in terms of improving cognition in the early stages of the disease—is Biogen’s new drug aducanumab, currently under review by the Food and Drug Administration (FDA) for approval. If approved, aducanumab would be the first-ever drug to slow the progression of Alzheimer’s and first-ever drug to treat mild cognitive impairment. Early-stage Alzheimer’s has not been afforded a new approved therapy in more than 17 years. No other major disease of Alzheimer’s scale and mortality has gone that long without incremental therapeutic relief.


George Vradenburg, the UsAgainstAlzheimer’s chairman and co-founder, testified last fall at an FDA panel considering the merits of aducanumab, “If we wait for the perfect drug or perfect data, we will descend further into the grip of this awful disease…People staring into the abyss of Alzheimer’s deserve no less. I joined this battle against Alzheimer’s because my family has experienced three generations of Alzheimer’s over 40 years. At this pace, my children and grandchildren are in the Alzheimer’s bulls-eye.”


George and I were among several UsAgainstAlzheimer’s board members to speak to the advisory committee. Our comments to the committee and the FDA are made as advocates, caregivers or people living with the disease. Full disclosure: UsAgainstAlzheimer’s and its mission are supported by thousands of individuals, institutions, and companies – and Biogen is among those supporters.


Regrettably, the FDA advisory committee in November concluded that there was not enough evidence to support the effectiveness of the experimental drug, saying it was not “reasonable” to consider the research presented as “primary evidence of aducanumab for the treatment of Alzheimer’s disease.” Yet in testimony before the panel from those afflicted with Alzheimer’s and participants in an aducanumab trial said the Biogen drug showed significant improvements in slowing cognitive decline, and was a ray of hope on a bleak horizon.

The FDA is now considering the panel’s opinions regarding aducanumab. While a decision had been expected by early March, the FDA has extended its review March until June. It could approve this new disease-modifying therapy for use, or it could require additional clinical trials and studies that could delay approval for several more years.

Time kills deals…


In a follow-up letter to the FDA advocating ardently for aducanumab approval, George Vradenburg and Chief Operating Officer Russ Paulsen stressed, “Public comments from patients and patient advocateswere unanimously and unambiguously in favor of approval, and those comments also went one hundred percent unaddressed and unexplored. As patients and patient- advocates, we experienced a process that was designed to enlighten, but, instead, proved confusing and incomplete.”


There was no confusion in a recent UsAgainstAlzheimer’s A-LIST® survey showing that patients overwhelmingly value a new therapy that slows progression of symptoms. Eight out of ten survey respondents in early stages of Alzheimer’s “hope to have access to a treatment, if approved by the Food and Drug Administration, that would allow them to experience an additional year without worsening symptoms, even if there is a chance of side effects requiring close management by a physician,” the survey found.


Survey respondents with a diagnosis of Alzheimer’s or mild cognitive impairment described that a year of delay in the progression of their symptoms would be a “gift,” a better quality of life, a chance to continue on as they are, and more time to travel. And a year that slows the disease gives them more hope and time for a breakthrough. “Another more effective drug might become available during that year,” one person wrote.


Others wrote about what they thought would happen if they had to wait several more years for a disease-modifying therapy: “Losing the ability to drive, make decisions for myself, being able to take care of my daily functions. Both of my parents had Alzheimer’s, so I do understand the slow progress,” one wrote.


So what can you do about it?


You can write the FDA in support of aducanumab and urge others to write too.

I know the frontline of Alzheimer’s well. The disease took my maternal grandfather, my mother, and my paternal uncle, and before my father’s death, he too was diagnosed with dementia. Now Alzheimer’s has come for me. I was blessed to be asked to testify before the FDA panel in support of aducanumab, and said:

“We have in this country some of the brightest minds in the world, but Alzheimer’s has been a Rubik’s Cube for which so far there is no winning solution. The best we can do now is to slow the rate of cognitive and functional decline in the earlier stages of Alzheimer's. Yet, that’s a significant step!
“Biogen’s drug aducanumab won’t help me in my mid-stage in this journey, but to those in the early stages of the disease, it would offer hope where to date there has been no semblance of hope. It offers the chance to preserve independence for a longer period…This may not be ‘victory-at-last’ on the medical front for those on this serpentine journey. But even if aducanumab is not a perfect drug for everyone, it is a big step forward that offers more time and real hope to many in this disease.”

And so my prayer today is that we all continue to raise strong, supportive voices for FDA approval of aducanumab. Too much is at stake.


Let’s not let time kill this deal.


Source


Greg O’Brien, a career journalist, is a member of the board of UsAgainstAlzheimer’s. He is author of the international award-winning On Pluto: Inside the Mind of Alzheimer’s.


 

Greg O'Brien

Greg O’Brien is author of On Pluto: Inside the Mind of Alzheimer’s, the first book written by an investigative journalist embedded inside the mind of Alzheimer’s chronicling the progressions of his own disease. He is a member of the Board of Directors of UsAgainstAlzheimer’s.





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