FDA and Biogen discussed Aduhelm's accelerated approval as early as 2019 — report
Top FDA neuroscience official Billy Dunn has been a vocal advocate for Biogen and its Alzheimer’s drug Aduhelm throughout the entire review process all the way up to the drug’s divisive accelerated approval. That enthusiasm — which had drawn the ire of advocacy groups and the adcomm of outside experts — seems to stem from a series of meetings between the company and Dunn dating back as far as 2019, STAT reports, when the Cambridge, MA drugmaker launched a secret campaign dubbed Project Onyx to win approval for aducanumab.
Those meetings led to discussions with officials in Dunn’s office about the use of the accelerated approval pathway to move Aduhelm through the line. The use of that pathway is what Harvard medical school professor and adcomm member Aaron Kesselheim attributed to his departure from the FDA committee. By June 2019, just a month after Biogen executives met with Dunn, officials in his office proposed the accelerated approval route — despite documents from the FDA that said the agency first discussed the possibility of accelerated approval on March 31, according to the STAT report.
“It was clear that Billy Dunn was an ally, so the job for Biogen became figuring out how to support his efforts within the FDA,” a former Biogen employee anonymously told STAT.
The FDA granted aducanumab — now marketed as Aduhelm — approval in early June, as the first drug to slow the progression of Alzheimer’s. In the years leading up to the OK, nearly every effort to treat Alzheimer’s had failed, even as the number of Americans living with the disorder grew to more than 6 million. The last approved drug came in 2003 and only temporarily boosts memory. The approval remains highly controversial as the FDA ignored the near-unanimous recommendation of its advisory committee, which said Biogen cherry-picked data after the drug failed two clinical trials.
Aducanumab seemed dead in the water in 2019 when data from those two clinical trials showed a flop on the primary endpoints. Biogen’s stock dropped 30% and the company lost $16 billion in market value. When scientists later found in post hoc analyses that the drug did demonstrate effectiveness against Alzheimer’s, Biogen reached out to Dunn and asked for his help. Nearly immediately after, chief scientist Al Sandrock met with Dunn in Philadelphia for an off-the-record, off-the-books meeting, STAT reported.
Dunn, now the director of the FDA’s office of neuroscience, laid out a red carpet for the company, offering a hearty endorsement of the drug despite what Caleb Alexander, an epidemiologist at Johns Hopkins University and adcomm member, called “dozens of red flags” in the data in front of a room filled with skeptics.
During that November 2020 panel discussion, Dunn brushed aside an FDA statistician’s concerns about the lack of efficacy. His tone was deemed promotional.
“At times, Dunn was advocating more strongly for Aduhelm than [Samantha] Budd Haeberlein, the Biogen executive presenting the company’s clinical data,” the STAT story reads. “When she struggled to answer questions posed by the panel, Dunn stepped in to respond.”
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee resigned after the approval, with Kesselheim calling it “probably the worst drug approval decision in recent U.S. history.”