Controversy after Biogen’s Alzheimer’s drug, Aduhelm gets accelerated FDA approval

The FDA’s decision to approve the first drug for the disease since met with mixed reactions.

The surprising move comes after the drug suffered a regulatory setback late last year after an independent panel of experts advised the FDA the available trial data did not show the drug, Aduhelm (aducanumab), to be effective for the treatment of Alzheimer’s disease. In protest following the recent approval, Aaron Kesselheim, who sat on the panel that rejected the drug last year tweeted, Accelerated Approval is not supposed to be the backup that you use when your clinical trial data are not good enough for regular approval”. Along with two other members, he subsequently resigned from the panel after labelling the FDA’s decision as “probably the worst drug approval decision in recent U.S. history”.

Aduhelm is the first drug approved for the disease since 2003. Expected to sell for about $56,000 a year, the drug’s approval was met with jubilation by Biogen’s executives. According to the FDA, the drug is a first-of-its-kind treatment approved for Alzheimer’s disease. While currently available treatments only address the disease’s symptoms, aducanumab is regarded as the first to target the disease’s pathophysiology process. Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks. To date, its specific causes are not fully known. It is the most common form of dementia, accounting for 60-70% of the 50 million cases of dementia worldwide.