Biogen (BIIB) Submit Final Aduhelm Protocol to FDA, What’s Next?

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Ollie Martin
Updated: 30 Mar 2022

Key points:

  • Aduhelm might be finally nearing FDA clearance as a potential game-changer for Alzheimers
  • The company submitted its final Phase 4 ‘Envison' trial to the FDA this morning
  • The first patient is expected to enter screening in May 2022

Alzheimer's has been a critical focus since the dawn of modern medicine. The lack of treatment surrounding the popular disease hasn’t changed much significantly in the last few decades as progress is slow and conservative. Biogen (NASDAQ: BIIB) has become the recent face of Alzheimer's treatment with a potentially revolutionary new treatment, Aduhelm. In production for around 10 years, Aduhelm has the potential to be the first treatment to really gain traction in limiting the speed that which Alzheimer’s escalates. 


Up until recently, Biogen appeared to be going in circles; claiming it didn’t work, then it did, etc etc. Stock prices shot up in mid-2021 with investing pouring in to grab a slice of the revolutionary new treatment. Since then, however, value has depreciated with Aduhelm still yet to reach the market. Today marks progress for the company; Biogen has just announced it has submitted the final Phase 4 ‘Envision’ trial to the FDA, awaiting imminent approval. With real progress finally on the horizon, biogen expects the first patient to enter screening in May 2022, with the completion of the trial around 4 years after the study begins. 

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The study will be a global, placebo-controlled trial with the aim of enrolling around 1,500 patients with early Alzheimer's disease; with a heightened focus on diversity and underrepresented demographics, as made clear by Samantha Budd Haeberlein, Ph.D., SVP, Head of Neurodegeneration Development at Biogen:

“Our unwavering commitment is to ensure that the trial is completed swiftly and that the diversity of patients in it reflects that of Americans diagnosed with early Alzheimer’s disease…We plan to work hand-in-hand with underrepresented communities and Alzheimer’s disease groups to achieve our diversity and inclusion goal.”

Biogen is nearly their final end goal, but it will still be a number of years before Aduhelm reaches the market and before it is reflected in the company’s financial fundamentals. Investors should be particularly aware of news-induced volatility when it comes to pharmaceutical stocks, one slight delay or objection from the FDA could easily spark a heavy sell-off. 


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