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FDA Sets Up Afrezza Panel To Split Between Type 1 And 2 Diabetes

 
• By Sue Sutter

Agency briefing documents for April 1 meeting suggest greater efficacy concerns in type 1 diabetics, although review of most recent trial in type 2 patients cites “surprisingly modest” treatment effects compared to other drugs. Safety issues for panel consideration include pulmonary function effects and lung cancer.

FDA appears to be laying the groundwork for potential approval of MannKind Corp.’s inhaled insulin Afrezza in one, but not necessarily both, types of diabetes patients.

At an April 1 meeting, the agency will ask its Endocrinologic and Metabolic Drugs Advisory Committee to vote separately on...

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More from North America

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• By Sue Sutter

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• By Sue Sutter

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Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

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