06-13-2021, 07:38 PM
- FDA approval of Biogen’s Alzheimer’s drug Aduhelm has sparked a major controversy in dementia treatment.
- More than 6 million Americans suffer from Alzheimer’s or other dementias, the sixth-leading cause of death in the U.S., and by some industry estimates the number of sufferers could double in the decades ahead.
- Several high-profile FDA panel advisors quit after the controversial Biogen drug approval, which could generate billions of dollars in sales, but others advisors and dementia experts say it may be a more hopeful moment for the brain disease pipeline.
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The FDA’s approval of Biogen’s Alzheimer’s drug Aduhelm was a landmark moment in the life of Dr. Paul Aisen. The director of the Alzheimer’s Therapeutic Research Institute at USC has spent the past three decades focused on treating the neurodegenerative disease, and in recent years helped shepherd this particular drug through the various phases of clinical trials.
But sitting in his sun-drenched office in San Diego in early June, he felt slightly confounded by the manner in which the Food and Drug Administration early June approved its use on an “accelerated” basis, which is usually reserved for cancer medications. This meant its clinical benefits were considered likely, but approval for long-term use would be subject to more extensive study in a fourth phase of trials.
Highlighting the “unusual nature” of the regulator’s green light, given that an advisory board of experts had strongly, and publicly, opposed the approval, Aisen, who works as a paid consultant to Biogen, insists there were still “a lot of questions that I have — that do not yet have answers.”
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