Sanofi/Regeneron Pharmaceuticals Inc.'s IL-4/IL-13 inhibitor Dupixent (dupilumab) was approved by the US FDA for a new indication, moderate-to-severe asthma, with a broad label that will make the treatment tough new competition for other biologics approved for severe asthma.
The FDA approved Dupixent Oct. 19 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. Other biologics approved for asthma, including AstraZeneca PLC's Fasenra (benralizumab), GlaxoSmithKline PLC's Nucala (mepolizumab) and Teva Pharmaceutical Industries Ltd.'s Cinqair (reslizumab), are all IL-5 inhibitors approved for severe eosinophilic asthma