Dupixent FDA Asthma Review Bolsters Sanofi And Regeneron
Already approved for atopic dermatitis, the partners have got a PDUFA date of Oct. 20 which could expand the label on their interleukin-4 and -13 inhibitor to include asthma.
You may also be interested in...
Several biologic drugs are now available for the 10% of asthma patients with severe uncontrolled disease, and Dupixent could join them later this year, setting the therapy area up for a competitive showdown.
Phase III studies testing Dupixent in moderate-to-severe asthma were largely positive, but subgroup details raise questions about how it will compete against biologics targeting the IL-5 pathway. Some experts urge comparison trials to inform physicians' decisions about long-term use.
Positive top-line Phase III results have been released on the use of Sanofi/Regeneron's Dupixent in adolescents with moderate-to-severe atopic dermatitis, adding to the evidence supporting its use in adults.