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.”
Three members of the FDA panel overseeing research have resigned since the approval this week, including Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, who said in a letter the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history.”
Last November, in an 8-1 vote, that panel said Biogen’s late-stage study didn’t provide “strong evidence” showing that aducanumab effectively treated Alzheimer’s; two other panelists said it the data was “uncertain.”