Aduhelm by Biogen
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…