GlaxoSmithKline (GSK) has submitted a supplemental Biologics License Application (sBLA) to the US FDA, seeking approval of mepolizumab. The drug is an interleukin-5 (IL-5) antagonist designed as an add-on to maintenance treatment for COPD patients with an eosinophilic phenotype, according to GSK.
Mepolizumab (as “Nucala”) is already approved for use in the US as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. In addition, Nucala has also been approved for severe eosinophilic asthma in the EU, Japan and a number of other countries worldwide.
GSK noted that this is the first time the drug has been submitted to potentially treat COPD and is not currently approved to treat COPD in any country. The submission includes phase III data from the previously reported METREX and METREO studies.
The drug is a first-in-class monoclonal antibody that targets the signalling protein IL-5. Mepolizumab binds to IL-5, preventing it from binding to its receptor on the surface of white blood cells called eosinophils. Inhibiting IL-5 binding in this way reduces blood eosinophils, which are believed to play a role in protecting the body against infection, but in some people can cause inflammation and are involved in the development of some inflammatory diseases. Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils.
GSK reported that regulatory filings in other countries are planned during the course of 2017 and 2018.
More information, including safety info, is available at the GlaxoSmithKline website.
