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Humira, Cimzia Arthritis Indications May Rest On Adequacy Of Classification Criteria

 
• By Sue Sutter

FDA’s Arthritis Advisory Committee will consider whether axial spondyloarthritis can serve as the basis for a new indication for AbbVie and UCB’s TNF inhibitors. Agency’s briefing documents raise concerns that classification criteria used in pivotal studies capture a patient population that is too broad and heterogeneous.

FDA will ask its Arthritis Advisory Committee at a July 22-23 meeting whether axial spondyloarthritis is a sufficiently well understood and defined population to support new indications for two TNF inhibitors.

The panel will be asked to consider whether recently developed criteria for classifying patients with axial spondyloarthritis (axial SpA), a...

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More from United States

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• By Alaric DeArment

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US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

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More from North America

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

Pharma Cooperating With Trump On Direct Sale To Consumers, Pfizer CEO Says

 
• By Jessica Merrill

Pfizer is in active discussions with Trump on MFN pricing and collaborating with peers on direct sales as an approach to lower drug prices, CEO Albert Bourla said.

Cuban: Drugmakers Are More Afraid of PBMs Than Trump

 
• By Leslie Small

The billionaire investor said during a recent conference that brand drug manufacturers want to work with his Cost Plus Drug Co., but are afraid the PBMs will retaliate.