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US FDA Rejection Stings Nucala In COPD; New Study May Be Needed

 
• By Emily Hayes

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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Prospects for GlaxoSmithKline PLC’s Nucala in COPD look dim but not stamped out after a complete response letter from the US FDA, amid regulatory unease about the use of eosinophil count as a biomarker to guide treatment for this condition.

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