The efficacy and future of Biogen's potentially game-changing Alzheimer's drug, aducanumab, has been cast into doubt following a vote from a scientific panel which went against the positive conclusions found by the FDA on Friday.
aducanumab trials
The somewhat combative panel voted that Biogen's main trial data did not provide enough evidence that the treatment worked.
Investors and people suffering from Alzheimer's disease have been watching developments and deliberations over aducanumab closely. If approved, it would be the first new drug for the treatment of the disease since 2003.
Just last week, shares in Biogen skyrocketed by 44% when the news that the US FDA researchers announced there was "substantial evidence" that the drug was effective.
However, at a meeting of the FDA's advisory panel that took place last Friday, many scientists criticised the trials as being inadequate and incomplete, with some attacking the regulator for pushing ahead with the approval process.
Scott Emerson, emeritus professor of biostatistics at the University of Washington, said that Biogen had been cherry-picking data to prove the drug works, comparing it to “someone first firing a shotgun at a barn and then painting a target around the bullet holes”.
It was noted by Caleb Alexander, professor at John Hopkins Bloomberg School of Public Health that the FDA assessment appeared to use the same language provided by Biogen.
Of the 11-member panel, ten members voted that the evidence was insufficient, with one member voting "uncertain".
Michel Vounatsos, Biogen CEO, said the company "appreciated the opportunity" to share data with the panel and offered thanks to patients who had shared their experiences.
The final decision will be led by the FDA office of neuroscience acting director Billy Dunn who is not bound by the advisory panel's views.
Biogen is applying for approval on the basis of one successful trial and a data subset from another trial that missed its goal. The company has been urged by the National Center for Health Research and other advocates to conduct a new trial.
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