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Birth Of A Biomarker? FDA Doesn't Define Eosinophilic Asthma, Defers To Docs On Nucala

 
• By Bridget Silverman

FDA declined to codify new asthma phenotype in the indication for GSK's Nucala, leaving emerging definition of eosinophilic asthma to the medical community. For FDA's endorsement, it is not enough to show that patients with eosinophilia biomarkers benefit; you also need to show that patients without the biomarker do not benefit.

FDA's approval of GlaxoSmithKline PLC's Nucala is a big step toward recognition of a severe asthma phenotype characterized by elevated eosinophils, but the agency chose to defer to the medical community on the task of how to use the biomarker to identify patients.

"Consensus on defining patients based on an eosinophilic characteristic has been challenging," Office of Drug Evaluation II Deputy Director Mary...

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