Aducanumab approval: Letter from the Editor

By C. SImone Fishburn, Editor in chief

June 12, 2021 3:45 AM UTC

This week, biotech saw one of its most momentous decisions since the industry’s foundation, with the FDA approval of Biogen’s aducanumab, an anti-amyloid mAb to treat Alzheimer’s disease.

The road has been long and hard, and it doesn’t end with this decision. BioCentury has documented the rise and fall and rise again of the amyloid hypothesis, one of the rare areas that stoke passions in the industry with hardened camps of believers and non-believers. The approval this week put FDA cleanly in the believers’ camp, but did little to convince the others. Passions remain high, and the evidence on which FDA made its decision has left stakeholders as polarized as they were before.

This week’s collection is a special edition of BioCentury, exploring the implications of the decision for payers, the next amyloid therapies in line, other Alzheimer’s drug developers, and the future of drug development in neurodegeneration. It includes viewpoints from the different stakeholders, in addition to data analyses, the stock market response, and a podcast discussion by BioCentury editors.

BioCentury’s team has spoken with dozens of representatives across the industry. Some views are starkly consistent: few if any believe the drug will have a major impact on the disease broadly. Most see this as a seminal moment for drug development, the importance heightened by the huge patient population and the devastating toll the disease takes. None are impervious to the desperation felt by patients and their caregivers.

But views diverge on whether this was the right decision for patients, and whether it bolsters or harms FDA’s standing with the public, and with the industry.

FDA’s decision-making process, Biogen’s price for the drug, and the uncertainty surrounding access for the treatment have raised questions. Many believe, however, that beyond what it means for this drug, the decision could herald a more optimistic future for Alzheimer’s and other neurodegenerative diseases.

What’s clear is that this approval will continue to ripple through the industry, and the story is only half told.