Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi announced on Friday the joint receipt of positive opinion and recommendation for Dupixent (dupilumab), for the add-on maintenance treatment of severe asthma, from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The companies added that the CHMP has recommended Dupixent (dupilumab) for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.

Based on clinical data from the partnership's 2,888 adults and adolescents who participated in three pivotal trials from the global LIBERTY ASTHMA programme, including the Phase 3 QUEST and VENTURE trials, QUEST compared Dupixent vs. placebo in asthma patients inadequately controlled on a medium or high dose inhaled corticosteroid and a second controller medication. VENTURE compared Dupixent vs. placebo in oral corticosteroid dependent asthma patients.

According to the company, Dupixent is a human monoclonal antibody that inhibits the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that play a central role in type 2 inflammation that underlies specific types of asthma as well as several other allergic diseases. This effect is associated with the reduction of type 2 inflammatory biomarkers including FeNO, immunoglobulin E (IgE) and eotaxin-3 (CCL26).

In conjunction, the European Commission is expected to make a final decision on the application for Dupixent in the coming months, concluded the companies.