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Biogen Pledges Aduhelm Confirmatory Data By 2026, Renewing Spotlight On FDA’s Lengthy Original Plan

 
• By Jessica Merrill

Biogen's update on the timeline for running a confirmatory study of the Alzheimer's treatment is much faster than the nine years required by US FDA under the accelerated approval.

Biogen
Biogen plans to begin an Aduhelm confirmatory study in May • Source: Alamy

Biogen, Inc.’s Phase IV post-marketing confirmatory trial of Aduhelm for the treatment of Alzheimer’s disease is on track to begin enrolling patients in May 2022 with the expectation that data will be available in 2026 – once again raising questions about why FDA originally specified such a lengthy timeline for confirming the accelerated approval.

The plan outlined by Biogen means patients, physicians and payers will have to wait at least four years to see more solid clinical evidence on the effectiveness of Aduhelm at slowing the progression of Alzheimer’s disease, but the timeline is still

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• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
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In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

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• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.