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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 within the agency.

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• By Bridget Silverman

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Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

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HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.