The Underside of the Aducanumab Approval

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2021-07-02 21:30:14

Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine. All content is Derek’s own, and he does not in any way speak for his employer.

I would like to recommend this piece at Stat about the details of the Biogen aducanumab approval. It’s behind the paywall, but it’s a deeply reported piece from Adam Feuerstein, Matthew Herper, and Damian Garde about how in 2019 Biogen launched an effort to get their apparently failed drug approved by the FDA anyway. They called it “Project Onyx”, renamed from the original “Project Phoenix” after Biogen’s lawyers objected to the implications of that one.

A key moment was a face-to-face meeting between Biogen’s Al Sandrock and Billy Dunn at the FDA’s Office of Neuroscience. This took place when the two were separately attending a neuroscience meeting in Philadelphia, and it was not in any way an official contact between the company and the regulatory agency. This appears to have been contrary to FDA policy, on the face of it, and is at the very least worth knowing about – a former Biogen employee told Stat that after the meeting, “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 month after the meeting, the FDA proposed the idea of an accelerated approval designation for aducanumab to Biogen, a huge victory which seems to have taken even Biogen’s executives by surprise. And the FDA’s official statements about how they came to the accelerated approval idea say nothing about the Dunn/Sandrock meeting.

The Stat article has plenty of inside-baseball details on the strains inside Biogen over the last few years, as the company went from being flush with money and new drug approvals to finding itself depending on – of all things – getting an Alzheimer’s antibody approved. I often wondered what people in the company thought about that, and I kept imagining David Byrne’s voice saying “Well. . .how did I get here?” There’s also an excellent look at how the company charged ahead in 2019 with an interim of the aducanumab results, a decision that led to biostatistician Thomas Fleming resigning from the monitoring board. But the company was confident of a good readout, and at that point they really needed one. What they got instead was a “halted for futility” decision. If you trust that one, then the FDA approval never should have happened. If you trust the FDA approval, then the futility call was an idiotic and premature mistake. I don’t see much room for a third option.

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