Biogen has reversed its decision on aducanumab, submitting the drug for FDA approval
Seven months after initially calling off the worldwide trial for a potentially groundbreaking early Alzheimer’s disease treatment — called aducanumab — U.S. biotechnology company Biogen has reversed its decision. It plans to submit the drug for approval in early 2020.
At press time , Biogen, who developed the drug with Japanese pharmaceutical manufacturer Eisai, has announced its intention to move forward with a U.S. Food and Drug Administration (FDA) Biologics License Application in early 2020.
“There is some promising evidence from these trials of aducanumab that we might have the first drug that can slow down the progress in Alzheimer’s disease,” says University of Calgary professor of neurology Dr. Eric Smith, who was a co-investigator at the Calgary site of the trial.
If approved, aducanumab would be the first disease-modifying therapy option on the market for those living with Alzheimer’s disease — meaning a treatment that slows the rate of decline.
The aducanumab trial was initially called off following an interim “futility analysis” in late March 2019. In what Smith calls an “unusual situation,” Biogen reversed the decision in October after further analysis showed positive results in participants with early Alzheimer’s. These positive results came from a larger dataset made available after discontinuation that included more data from patients randomized to the higher doses of the drug.
According to Biogen, “Patients who received aducanumab experienced significant benefits on measures of cognition and function, such as memory and language.”
At the moment, the future of aducanumab is still uncertain. Smith notes that the results of the trial have yet to be published in any peer-reviewed medical literature. Also, Smith suggests that, due to the unusual circumstances regarding the reversal, the FDA could require another trial using the higher dose that yields positive results.
Calgarian Duncan McLean, a participant in a previous Biogen trial who is living with dementia, is encouraged by this new development. “It’s a positive thing that Biogen is going to continue their research,” he says. [ ]