In this episode, we took a deep dive into the history and steps of FDA approval of the latest Alzheimer’s drug, Aducanumab.
Developed by the biotechnology company Biogen, it is the first approved drug that attempts to treat a possible cause of the neurodegenerative disease rather than just the symptoms.
But the approval has sparked a contentious debate over whether the drug is effective. Many experts, including an independent panel of neurologists and biostatisticians, advised the FDA that clinical-trial data did not conclusively demonstrate that Aducanumab could slow cognitive decline.
Yet patient advocacy groups tout this as a miracle drug and one that provides hope and opens the doors for future therapeutics for this devastating disease.
In this episode, we discuss:
- The history of drug development for Alzheimer’s
- Amyloid and Tau protein targeting
- How this drug was presented in 2019, rejected, reapplication by Biogen, its reanalysis data, and final approval by FDA on June 7, 2021
- Side effects of the drug
- Price and the economics around the drug
- Long term consequences to the field