1. In Vivo

Aduhelm Shockwaves Will Reverberate Across Industry

 
• By Daniel Chancellor

The butterfly effect is an elegant analogy to describe the seemingly unpredictable and far-reaching implications of a relatively small and inconsequential event. The FDA’s approval of Aduhelm is not so much a butterfly gently flapping its wings, but rather a sonic boom emanating from a jet engine. Most immediately, it provides a new therapeutic option for millions of patients in dire need of hope, vindicating Biogen’s faith with a revenue stream running into many billions of dollars. Longer-term the reverberations may be felt across the entire industry, throwing into question the evidentiary requirement for drug development.

sonic boom
• Source: Alamy

The accelerated approval of Aduhelm (aducanumab) creates a momentous opportunity for Biogen, Inc., one that has long been sought after by a range of big pharmas with larger R&D budgets. Companies like Johnson & Johnson, Pfizer Inc., Eli Lilly and Company and Roche Holding AG have attempted to produce the first new drug for Alzheimer’s disease since memantine in 2003, coming up short and creating a discard pile containing almost 200 failed or suspended programs.

For Biogen, success equals access to the millions of patients currently living with the various stages of Alzheimer’s disease in...

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