A panel of medical experts convened by the FDA said data from clinical trials of Biogen's Alzheimer's drug aren't enough to prove the drug works and voted against FDA approval, STAT reported.
The experts, who met Nov. 6, contradicted a group of FDA reviewers who appeared to endorse the drug in a separate meeting Nov. 4. The FDA often convenes panels when it is uncertain if it should approve a new drug.
Biogen's drug, aducanumab, has faced controversy over its efficacy after two clinical trials showed different results. The trials were stopped because the drug seemed unlikely to provide a benefit to Alzheimer's patients, but a reanalysis showed that one of the two studies appeared to show benefit while the other didn't, STAT reported. FDA reviewers have previously said that a deep look into the trial data suggests that a small number of patients in one study may have skewed it.
The panel of 11 medical experts voted Nov. 6 that the data wasn't enough to show that the drug could slow cognitive decline in Alzheimer's patients. The decision to approve the drug ultimately lies with the FDA, but experts say it would be "extremely difficult" for the agency to approve the drug after the experts' vote, STAT reported.
"We think approving aducanumab, in the face of such an overwhelmingly negative vote and commentary, is virtually impossible and would destroy the agency’s reputation at a very tenuous time for the regulator, ahead of potential actions on COVID vaccines," Brian Skorney, an analyst at the investment bank Baird, wrote in a note to investors, according to STAT.
Some of the panelists accused the FDA of trying to explain away problems with the clinical trial data and said that the questions the agency submitted to the panel implied much stronger evidence of the drug's benefit than actually existed, STAT reported.
"I find the material FDA provided to be strikingly incongruent," Caleb Alexander, MD, an epidemiologist at Johns Hopkins University, told STAT, comparing the FDA’s positive clinical review and its negative biostatistical review to "audio and video that are out sync."
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