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As Aducanumab’s US FDA Review Progressed, Support Grew For Accelerated Approval

 
• By Sue Sutter

Use of expedited pathway for Biogen's Alzheimer's drug was discussed at a center director briefing in late April, where it garnered backing from several senior CDER officials, as well as CBER director Peter Marks and OCE director Richard Pazdur.

Momentum
The idea of accelerated approval gained momentum late in Aduhelm's regulatory review. • Source: Alamy

In November 2020, Biogen, Inc.'s Aduhelm (aducanumab-avwa) exited a US Food and Drug Administration advisory committee review with little to no support from the agency's external experts for regular approval, despite a strong endorsement by the FDA clinical review team and Office of Neuroscience leadership.

However, as the Alzheimer’s drug’s tangled regulatory review progressed, it gained backing for accelerated approval across multiple offices and centers...

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More from Approvals

PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
• By Eliza Slawther

PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

More from Product Reviews

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues

 
• By Sue Sutter

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.