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Aducanumab Approval Decision Delayed: Could This Be Good News?

Amendment Triggered Three-Month Review Extension

 
• By Mandy Jackson

Even analysts who still doubt the FDA will approve the anti-amyloid antibody as the first disease-modifying Alzheimer’s treatment said aducanumab’s likelihood of approval has improved.  

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The FDA requested more information on aducanumab and then delayed its approval decision until 7 June • Source: Shutterstock

Biogen, Inc./Eisai Co., Ltd.’s 29 January announcement that the US Food and Drug Administration’s review of aducanumab for the treatment of Alzheimer’s disease has been extended by three months, with a decision now expected on 7 June, continued the ongoing debate over the amyloid-clearing antibody’s approvability and raised new questions about what data the agency might require to make its decision.

Biogen provided information that the FDA requested as part of its review of the biologic license application, which the agency...

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China Signals Restarting IPOs For Unprofitable Biotechs

 
• By Dexter Jie Yan

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 
• By Mandy Jackson, Joseph Haas, and Sarah Karlin-Smith

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Syncona Looks To Go Private As Market Decline Deepens

 
• By Andrew McConaghie

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.