Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and biopharmaceutical company Sanofi on Tuesday announced the joint filing of an application for DUPIXENT (dupilumab) with the European Medicines Agency (EMA) for review for add-on maintenance treatment for inadequately controlled moderate-to-severe asthma.

People who live with inadequately controlled moderate-to-severe asthma often experience decreased ability to breathe (lung function) and have severe attacks (exacerbations) that may lead to emergency room visits and hospitalisations and is often associated with other Type 2 inflammatory diseases.

The companies added that DUPIXENT is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two important signaling proteins (cytokines) that contribute to Type 2 inflammation in inadequately controlled moderate-to-severe asthma.

This EMA application is supported by clinical data from the partnership's three pivotal trials with 2,888 adults and adolescents (12 years of age and older) from the LIBERTY ASTHMA clinical development programme

In conjunction,the details from the Phase 3 QUEST and VENTURE trials will be presented at the American Thoracic Society 2018 International Conference in May.

Concurrently, the US Food and Drug Administration is reviewing a supplemental Biologics License Application for DUPIXENT as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma, with a target action date of 20 October 2018.