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.
Nucala (mepolizumab) – a monoclonal antibody targeting interleukin-5 (IL-5) – was initially approved by the FDA in November 2015 as an add-on treatment for adults and adolescents who have severe asthma with an eosinophilic phenotype
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