Biogen announced on July 8, 2020 that the company is seeking U.S. approval for the drug aducanumab. If granted approval by the Food and Drug Administration (FDA), the drug would be the first one on the market to slow the progression of Alzheimer’s disease.
Biogen claims that aducanumab removes beta amyloid beta which improves clinical outcomes in Alzheimer’s. Results from phase 3 trials in adults with early-stage disease show that treatment with aducanumab reduced decline in cognition, memory, language, and activities of daily living performance.
Studies of aducanumab were halted in March 2019 when data analysis demonstrated ineffectiveness of the drug. However, subsequent data analysis showed success with higher doses.
The new data interpretation has been met with skepticism by experts who are unsure if aducanumab will be rewarded with FDA approval. It has been at least 15 years since the FDA has reviewed an application for a new Alzheimer’s treatment.
By: Samuel Won, PharmD Candidate 2021
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