FDA green light for Dupixent in important asthma indication

The US Food and Drug Administration has approved Dupixent (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Co-developed by France’s Sanofi (Euronext: SAN) and US biotech Regeneron Pharmaceuticals (Nasdaq: REGN). Dupixent inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide (FeNO), immunoglobulin E (IgE) and eotaxin-3 (CCL26).

Launched in the USA in April 2017, Dupixent is seen as a key revenue driver for Sanofi, and generated worldwide sales of 176 million euros ($202.5 million) in the second quarter of this year.