US regulators have accepted for review Sanofi/Regeneron’s biologic Dupixent as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma.
Dupixent is a human monoclonal antibody specifically designed to inhibit signaling of interleukin-4 (IL-4) and IL-13, two key signaling proteins that contribute to type II inflammation in moderate-to-severe asthma. The drug is already on the market as a treatment for atopic dermatitis.
The submission for asthma includes data from the Phase III LIBERTY ASTHMA VENTURE study, which showed that adding Dupixent (dupilumab) to standard therapies significantly cut the use of maintenance oral corticosteroids (OCS) by 70 percent on average, compared to 42 percent with placebo.
The drug was also shown to significantly slash OCS use by 80 percent on average compared to 43 percent for placebo in patients with baseline eosinophil counts greater than or equal to 300 cells/microliter.
Also, at 24 weeks, despite the reduced use of OCS, compared to placebo patients taking the drug had 59 percent fewer attacks in the overall population and 71 percent fewer attacks in patients with eosinophil counts greater than or equal to 300 cells/microliter.
Sanofi said it expects a decision by the US Food and Drug Administration by October 20 this year 2018.