Posted by Michael Wonder on 09 Sep 2018
GSK receives complete response letter from US FDA for use of mepolizumab in COPD patients
7 September 2018 - GlaxoSmithKline today received a complete response letter from the US 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, guided by blood eosinophil counts.
The letter 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.
