In an interesting decision FDA decided on June 7 to approve a controversial new treatment for Alzheimer’s Disease, Aducanumab (trade name Aduhelm)
What is Aduhelm?
Aduhelm is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.
Why FDA Decided to Approve Aduhelm to Treat Alzheimer’s Disease https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease
Approval Path: Aduhelm was approved under the Accelerated Pathway. According to Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and ResearchCDER Director the “Accelerated Approval https://www.fda.gov/drugs/information-health-care-professionals-drugs/accelerated-approval-program pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.” Further, FDA consider Aduhelm a novel treatment. The last time a treatment for Alzheimer’s was approved was in 2003. Dr. Cavazzoni emphasized that “Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.”
Dr. Cavazzoni concluded that : “FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm.” https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease