1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition?

 
• By Brenda Sandburg

A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.

Two men change their common route taking different ways
FDA has previously parted ways with an advisory committee in approving a drug • Source: Shutterstock

The US Food and Drug Administration seemed ready to approve Biogen, Inc.’s Alzheimer’s disease drug aducanumab before an advisory committee voted that the sole positive Phase III study did not support the drug’s effectiveness. The question now is whether the agency will go through with approval or require Biogen to conduct an additional trial. A look back at other instances in which the FDA approved a drug against a panel’s recommendation shows aducanumab’s unique circumstances, which may deter the agency from pushing forward with approval.

Members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee sharply criticized the agency for its analysis of aducanumab...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.