Glaxo Set To File Nucala In COPD, Despite Mixed Phase III Results
An 'imperfect biomarker' – that's how a New England Journal of Medicine editorial describes the eosinophil count used in METREX and METREO studies.
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US FDA Rejection Stings Nucala In COPD; New Study May Be Needed
Mepolizumab would be first drug for chronic obstructive pulmonary disorder to use eosinophil count as a biomarker, but FDA’s complete response letter says more clinical data are needed.
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US FDA was hoping Pulmonary-Allergy Drugs Advisory Committee could help provide some clarity on its use, but there still are many questions.