There is New Hope for Patients with Alzheimer's

Today the FDA approved for the first time ever a drug that is advertised to help delay the progress of the disease in early stages of Alzheimer’s. The drug is from Biogen aducanumab and is marketed as Aduhelm, the drug was approved using the accelerated approval program due to it's influence on aggregated amyloid beta which is one of the possible causes or effects of Alzheimer’s as it collects between neurons disrupting the communication between those neurons.

During two identical phase III studies the drug was shown to reduce cognitive decline in one of the studies but not in the other. As a result, the FDA advisory committee in November 2020 declined to endorse the experimental drug citing both studies should be taken into consideration. Biogen suggested that failure in one trial did not detract from the findings of the other. The director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research agreed with Biogen and emphasized the urgent need for the Alzheimer’s treatment.

"We are well-aware of the attention surrounding this approval," the FDA wrote in a press release announcing the decision. "We understand that Aduhelm has garnered the attention of the press, the Alzheimer's patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review."

"At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward," the agency added. Some medical professionals have stated that they will not prescribe the new medication because of the mixed results.

The FDA will continue to monitor aducanumab and is requiring that Biogen conduct a post-approval clinical trial to verify the drug’s clinical benefit. The FDA can take steps to remove the drug from the market if it does not work as intended.