FDA rejects Glaxo's Nucala in COPD

GlaxoSmithKline (NYSE:GSK) has received a Complete Response Letter (CRL) from the FDA related to its marketing application seeking approval for NUCALA (mepolizumab) as add-on therapy to inhaled corticosteroid-based maintenance treatment for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). The CRL cited the need for additional clinical data.

NUCALA was approved in the U.S. in November 2015 for severe asthma and in December 2017 for eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)..