GlaxoSmithKline received a complete response letter (CRL) from the FDA regarding its application for mepolizumab 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 CRL states that more clinical data are required to support an approval. GSK will work closely with the FDA to determine the appropriate next steps for the supplementary biologics licence application (sBLA).
First approved in 2015 for severe eosinophilic asthma, and also licenced for EGPA in the US, mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood eosinophils.
Mepolizumab has been studied in over 3000 patients in 16 clinical trials across a number of eosinophilic indications and is currently being investigated for severe hypereosinophilic syndrome and nasal polyposis, in addition to the sBLA filed for the treatment of patients with COPD.