The Food and Drug Administration’s accelerated approval of the drug aducanumab for the treatment of Alzheimer’s disease is mired in controversy — three scientists have resigned from the independent committee that advised the agency on the monthly infusion treatment priced at $56,000 per year.

C. Michael White, distinguished professor and head of the Department of Pharmacy Practice at the University of Connecticut, explains the situation surrounding the drug’s approval this week in an essay published by The Conversation:

Over 6 million Americans now have Alzheimer’s disease, and deaths from Alzheimer’s have risen over 145% over the past 20 years. Alzheimer’s disease not only robs individuals of their autonomy but also places a huge burden on family members and the U.S. economy: $355 billion is spent annually on caring for people with Alzheimer’s. Current FDA-approved treatments are only modestly effective at controlling disease symptoms, and none target a possible underlying cause.

The accelerated approval pathway allows patients with early-stage Alzheimer’s to access aducanumab while a larger and more definitive clinical trial is conducted. Biogen says it hopes to have the clinical trial completed by 2030. If the study does not find reductions in the hard clinical endpoints, the drug will be withdrawn.

If aducanumab is ultimately found to be effective, many patients with early-stage Alzheimer’s will reap the benefits in reductions in hospitalizations, doctor visits, nursing home costs and societal burden.

If aducanumab is found to be ineffective, however, Medicare, insurers and patients will have spent tens of millions of dollars on a drug that not only did not work but also exposed patients to adverse events, including the risk of bleeding in the brain.  June 10 – The Conversation 

Dr. C. Michael White is an expert in the areas of comparative effectiveness and preventing adverse events from drugs, devices, dietary supplements, and illicit substances. If you are a journalist looking to cover this topic, then let us help. Dr. White is available to speak with media — click on his icon now to arrange an interview today.