1. Pink Sheet
  2. >>Product Reviews
  3. >>Post-Marketing Regulation & Studies

Biogen Closes The Book On The Aduhelm Saga

 
• By Jessica Merrill

Biogen will end the development and commercialization of Aduhelm, the first anti-amyloid antibody drug to reach the US market for Alzheimer’s, including the confirmatory ENVISION trial. Product’s legacy includes an FDA that appears less enthusiastic about accelerated approvals for large indications and a CMS that is more interested in label-driven reimbursement decisions.

closed book
Biogen is ending development and commercialization of Aduhelm • Source: Shutterstock

Biogen, Inc.'s decade-long Aduhelm (aducanumab) story line took many twists and turns over the course of its development, capturing national attention in 2021 when the drug became the first anti-amyloid antibody to reach the US market for Alzheimer’s disease on scant efficacy evidence and quickly fading from the spotlight when the hyped commercial launch failed and a second anti-amyloid drug from Eisai Co., Ltd. and Biogen, Leqembi (lecanemab), gained full approval from the US Food and Drug Administration in 2023.

Key Takeaways
  • Biogen will discontinue the development and commercialization of Aduhelm, including the ongoing Phase IV confirmatory trial ENVISION.

Now, without any fanfare and as many watchers and investors expected, Biogen announced on 31 January that it will discontinue...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Post-Marketing Regulation & Studies

US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By Kate Rawson

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

 
• By Grace Moser

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

More from Product Reviews

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
• By Bridget Silverman

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

Will US FDA’s Leadership Rediscover The Value Of Advisory Committees?

 
• By Michael McCaughan

After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.

New EU Filings

 
• By Neena Brizmohun

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.