The pressure was on. Researchers had been studying Alzheimer’s for decades. Every morsel of discovery was hailed as moving closer to a cure and results were always expected soon after the discovery. Treatments that are currently available simply improve the performance of chemicals in the brain. However, they do not stop the death of brain cells.
According to a recent article in Medcity News, Biogen’s new drug, Aduhelm attacks the problem from a different perspective. The drug is designed to remove amyloid plaques found in the brain. Yet to date there has been no research proving that removal of the plaque will slow the progression of the disease.
The protein, beta-amyloid (plaques), appears in microscopic clumps that are characteristic of Alzheimer’s disease.
About Aduhelm (aducanumab)
Aduhelm uses human antibodies for the primary purpose of removing the toxic brain protein, amyloid. Amyloid deposits are known to be associated with Alzheimer’s. However, there has been no conclusive evidence that if the plaques are removed, the disease progression will diminish.
Aduhelm is infused for one hour in a clinical setting at one-month intervals. The wholesale cost of the drug is $56,000 per year not including discounts or rebates.
The president of Biogen’s operations in the U.S. believes that since Alzheimer’s mostly affects the elderly, most patients are covered by Medicare or have private insurance.
About Accelerated Approval
Accelerated approvals are based on signs from clinical trials indicating that the experimental drug may be successful. This designation will bring the drug to market faster although patient benefit has not yet been proven. Additional clinical trials will be conducted after the drug is on the market.
Accelerated approvals are usually granted when reviewing drugs for rare diseases or cancer where there are very limited treatments available. In these instances, accelerated approval is based on data from a Phase 1 or Phase 2 trial.
In the case of Aduhelm however, the drug had reached Phase 3 trials.
In 2019, Biogen stopped two of its Phase 3 trials of Aduhelm basing their decision on data showing that the studies were not going to be successful.
Then Biogen conducted a reanalysis of the same data finding that one of the Phase 3 studies showed that administered in high doses, Aduhelm successfully slowed cognitive decline.
Yet the FDA did not base its decision on the Phase 3 clinical trial. Instead, it referred to its observation that a reduction in amyloid protein was found in Alzheimer’s patients across each of Biogen’s studies.
An Eight-Year Confirmatory Trial
The FDA’s letter of approval for Aduhelm allows a target date of August 2029. A draft of Biogen’s clinical trial protocol is due by October with the final protocol presented by August of 2022. The trial’s final report is due within the next six months after trial completion.
Biogen estimates that there are approximately nine hundred sites across the country ready to receive the drug. The company anticipates shipping Aduhelm within the next two weeks.