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The Ups And Downs Of Aducanumab’s Rollercoaster Development Program

 
• By Nielsen Hobbs

The Biogen Alzheimer’s product saw its ‘likelihood of approval’ score from Biomedtracker change directions multiple times as it moved through clinical trials and US FDA review.

• Source: Alamy

Before its approval by the US FDA on 7 June, Biogen Pharma and Eisai Co., Ltd.’s Alzheimer’s drug aducanumab had a rollercoaster of a development program, from trials terminated for futility that end up being the basis of submission to an apparent advisory committee slam dunk that was actually anything but.

Below we chart that story through the changes to aducanumab’s ‘Likelihood Of Approval’ score from Informa Pharma Intelligence’s Biomedtracker....

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More from Approvals

Where RWE Studies Stand In India And Bharat Serums’ Plans For The World’s Largest One

 
• By Vibha Ravi

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

Patient Perception-Of-Change Videos Not Efficacy Evidence For Stealth Barth Syndrome Drug

 
• By Sue Sutter

FDA reviewers cited several limitations of the videos, including a lengthy recall period, use of the term “today” in questions, and a lack of standardization in interview conduct.

Forzinity Chronology: Stealth’s Barth Syndrome Drug Bounced Around US FDA Review Divisions

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the clinical development and US FDA review timeline for Stealth's elamipretide for Barth syndrome.

With Forzinity, US FDA Accelerated Approval Still Can Precede Confirmatory Trial Enrollment

 
• By Sue Sutter

Stealth BioTherapeutics' diligent response to the FDA’s accelerated approval suggestion, its justification for proposed confirmatory trial milestones, and the rarity of Barth syndrome gave the agency confidence to grant approval before the postmarketing study began.

More from Product Reviews

Novel US FDA Approvals Could Heat Up November, But Will Annual Count Beat 2024?

 
• By Bridget Silverman

Eight novel agents have user fee goal dates in November, which keeps the possibility of matching or topping the 2024 annual count alive.

Former US FDA CDER Director Says He Played Key Role In Stealth’s Elamipretide Approval

 
• By Sarah Karlin-Smith

Recently departed CDER Director George Tidmarsh publicly touted his own role in reviewing Stealth's elamipretide data and guiding the division on the last-minute accelerated approval, though his name is absent from the review documents.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Winlevi (clascoterone), Cosmo Pharmaceuticals/Cassiopea's treatment for acne vulgaris.