BRIEF—GSK files sBLA for COPD drug mepolizumab

GlaxoSmithKline has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration, seeking approval of mepolizumab, an interleukin-5 (IL-5) antagonist, as an add-on to maintenance treatment for patients who have chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

The submission includes Phase III data from the previously reported METREX and METREO studies.

Under the trade name Nucala, the drug is approved and marketed for the treatment of asthma by the UK pharma major.

Mepolizumab is not approved anywhere in the world for COPD.

The submission to the FDA is the first to a regulatory authority for mepolizumab for COPD. Regulatory filings in other countries are planned during the course of 2017 and 2018.