Why FDA’s approval of aducanumab was unprecedented 

The backlash surrounding aducanumab post-approval has put Biogen (NSDQ:BIIB) on the defensive, prompting the company’s head of research and development, Dr. Alfred Sandrock, to post an open letter to the Alzheimer’s disease community on Biogen’s website. In the letter, Sandrock lamented that there was “extensive misinformation and misunderstanding” regarding the drug.

In recent weeks, the company also requested that the FDA narrow the indication for the drug to focus on Alzheimer’s patients with mild cognitive impairment or mild dementia. The FDA had initially indicated it for all Alzheimer’s patients even though clinical trials focused on patients with milder forms of the disease.

The collaboration between FDA staff and Biogen

FDA closely worked with Biogen during the approval process of aducanumab. Critics such as Public Citizen have called the cooperation between the two organizations “unprecedented” and “inappropriately close.”

FDA had viewed data fr…

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