FDA: More Data Required to Support Mepolizumab Approval for COPD

In their Complete Response Letter, the FDA stated that they require more clinical data to support approval.

The Food and Drug Administration (FDA) has issued a complete response letter (CRL) to GlaxoSmithKline stating that more clinical data is needed to support the approval of mepolizumab (Nucala) as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts.

The supplemental Biologics License Application (sBLA) included data from the METREX and METREO Phase 3 trials. Results showed that among COPD patients with an eosinophilic phenotype, mepolizumab 100mg was associated with a reduced rate of moderate to severe exacerbations compared with placebo; a greater effect was noted in patients with higher blood eosinophil counts at screening. In the METREO study, higher doses (300mg) were not linked to greater treatment effect.  

In a press release, GlaxoSmithKline stated that the they will work closely with the FDA to determine next steps for the sBLA. 

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Mepolizumab, an interleukin-5 antagonist monoclonal antibody, is currently indicated for add-on maintenance treatment of patients with severe asthma aged ≥12 years, and with an eosinophilic phenotype. It is also approved for the treatment of adults with eosinophilic granulomatosis with polyangiitis.

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