Investors unimpressed despite dupilumab data meeting endpoints

French pharma major Sanofi (Euronext: SAN) and US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) have announced that a pivotal Phase III study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints.

Dupilumab, marketed under the name Dupixent, is already approved in the USA for the treatment of moderate-to-severe atopic dermatitis (eczema) that is not adequately controlled with topical prescription therapies, and this new data suggests that an approval in asthma might not be far away.

When added to standard therapies, it reduced severe asthma attacks (exacerbations) and improved lung function in the LIBERTY ASTHMA QUEST trial, and the companies plan to submit a Supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) by the end of this year.