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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 the US. This is commonly cited as around six million,...

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