Posted by Michael Wonder on 20 Oct 2018
FDA approves asthma indication for Dupixent (dupilumab)
20 October 2018 - Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype.
The U.S. FDA 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.
The pivotal trial program evaluated 2,888 adult and adolescent patients with moderate-to- severe asthma in three randomized, placebo-controlled, multicenter trials (Trial 1, Trial 2 and Trial 3) for six months to one year (24 to 52 weeks). All trials enrolled patients irrespective of minimum baseline eosinophil levels.
