GlaxoSmithKline: FDA denies approval of COPD drug

(CercleFinance.com) - While GlaxoSmithKline has unveiled positive results on mepolizumab in the improvement of asthma control earlier today, the drugmaker has also announced a more disappointing outcome for mepolizumab in COPD patients.


Indeed, GSK today received a so-called "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 (COPD), guided by blood eosinophil counts.

The FDA's refusal says that more clinical data is needed to support an approval.

GSK said it will work closely with the FDA to determine the next steps to be taken for the application.

GSK shares are currently down 0.3% at 1,521 pence.

Copyright (c) 2018 CercleFinance.com. All rights reserved.