Questions About New FDA Approved Alzheimer’s Drug

McNair Dallas Law

FDA Approved Aducanumab

The US FDA approved a new drug designed to treat Alzheimer’s Disease earlier this month despite little evidence of its effectiveness.  The Los Angeles Times, in their article FDA Approves Much-Debated Alzheimer’s Drug Panned by Experts revealed that an advisory panel tasked with reviewing the drug’s performance in clinical trials recommended that the FDA hold off on approval.  Two clinical drug trials were stopped early because there was no clear evidence that the drug reversed cognitive decline.  Several members of the advisory committee have since resigned over the decision.

The drug, Aducanumab, developed by Biogen, Inc. will be expensive to administer since it requires a series of infusions followed by brain scans overseen by nurses or other medical professionals.  Biogen reports that the drug would cost approximately $56,000 per year on average.  For Medicare beneficiaries that could translate into $11,000 in coinsurance annually.

Aducanumab is the first drug to treat Alzheimer’s in close to 30 years, and the only drug approved to address the underlying disease process, rather than just the symptoms.  The lack of other medicines to treat Alzheimer’s Disease, along with the rise in the numbers of people diagnosed with the disease contributed the the FDA’s decision to approve the drug.  Dr. Patrizia Cavazzoni, Director of the FDA Center for Drug Evaluation and Research stated “The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages.”

Aducanumab was approved under an FDA policy called “accelerated approval pathway”.  This process requires that Biogen conducts follow-up studies to determine whether or not the drug is effective in patients outside a clinical trial.  The follow-up study should be completed by 2030.

For more information about Aducanumab or about Alzheimer’s Disease and other forms of Dementia, contact your local chapter of the Alzheimer’s Association.

Adapted from: https://www.latimes.com/science/story/2021-06-07/us-regulators-ok-alzheimers-drug-against-advice-of-experts

 

 

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