GlaxoSmithKline plc announced the submission of a supplemental Biologics License Application (sBLA) to the United States Food and Drug Administration (FDA), 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.
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.
COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both and limits airflow to the lungs, interfering with normal breathing. It is thought to affect 384 million people worldwide. It is currently the fourth leading cause of death in the world but is projected to be the third leading cause of death by 2020. COPD is a heterogenous disease and eosinophilic inflammation exists in a sub-set of patients.
Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.
For people living with COPD the inability to breathe normally and worsening of their symptoms can consume their daily life and make simple activities, like walking upstairs, an everyday struggle.
Every person with COPD is different, with different needs, different challenges and different goals. Understanding this, and providing support to help meet these needs is the foundation of GSK’s work.
Mepolizumab 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.
Mepolizumab is approved for use in the US under the brand name Nucala as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala has also been approved for severe eosinophilic asthma in the EU, Japan and a number of other countries worldwide, although the details of the indications may vary.
Mepolizumab has been filed in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). It is also being investigated for severe hypereosinophilic syndrome, nasal polyposis and atopic dermatitis.