- The approval of Biogen’s new Alzheimer’s drug has been widely debated and led regulatory three advisors to resign.
- New documents show that FDA experts were divided on the drug.
- Two of the people involved in reviewing the drug said hadn’t been shown to slow down the disease.
- See more stories on Insider’s business page.
Regulatory advisors and Alzheimer’s disease experts have decried the approval of a controversial new treatment since its approval on June 7.
But new documents released Tuesday show that there was dissent within the halls of the Food and Drug Administration about whether the drug should be approved.
The drug in question, Aduhelm, has been the subject of significant debate for the last two years. It will cost an average of $56,000 each year — far above expectations. Its approval could make it harder to develop and test better therapies, experts told Insider.
Three of the 10 experts who advise the FDA on nervous system drug applications have resigned in protest following the drug’s approval.
The 83 pages of internal FDA documents now show that at least two agency officials — Dr. Sylva Collins and Dr. Tristan Massie from the office of Biostatistics — also felt that it shouldn’t be approved.
Drug developer Biogen had originally stopped work on Aduhelm, then called aducanumab, in March 2019 after an initial look at the clinical trial data indicated the drug wasn’t working.
But it coalesced with FDA officials over the following months. Together, the organizations “virtually completed” the two clinical trials and determined the aducanumab might help patients, according to the agency documents.
Regulators met this spring to consider approval
Top regulators met at least three times in March and April to review Biogen’s application.
Massie felt there were inconsistencies in the data Biogen presented. But Dr. Peter Marks, director of the Center for Biologics Evaluation and Research and Dr. Patrizia Cavazzoni, director of Center for Drug Evaluation and Research, and others felt the data were “on face, highly persuasive.”
“We are left with conflicting information that is not readily resolved. We are also left with differing scientific perspectives from different members of the application review team,” the FDA’s Dr. Peter Stein wrote in a memo on June 7. But he followed that up by saying Aduhelm should be approved.
The FDA ultimately allowed Aduhelm to hit the market using a special mechanism called an accelerated approval, which allows for the use of drugs that are reasonably likely to have a benefit for patients even when there is uncertainty about how well they work.
Accelerated approvals are usually only used when it would take several years to show the drug benefitted patients, but there is a clear biological signal that shows it will work. To use it in the Aduhelm case was unusual, one FDA official said in a memo.
This regulatory decision has also raised eyebrows because there were cases of brain swelling and bleeds linked in Aduhelm during the human trials.
Biogen has until 2030 to run a follow-up trial and prove Aduhelm slows down the spread of Alzheimer’s.