GSK's Nucala For COPD Faces Questions On Efficacy Results, Missing Data
US FDA advisory committee will consider impact of trial design, given that GSK did not collect asthma histories and chronic oral corticosteroid use information from its COPD study participants.
You may also be interested in...
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.
US FDA was hoping Pulmonary-Allergy Drugs Advisory Committee could help provide some clarity on its use, but there still are many questions.
Unclear data on monoclonal antibody's efficacy caused many members of Pulmonary-Allergy Drugs Advisory Committee to vote against recommending approval.