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Dupixent FDA Asthma Review Bolsters Sanofi And Regeneron

Executive Summary

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.

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Severe Asthma Market Snapshot: A Competitive Therapy Area That Will Test Payers' Influence

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.

Dupixent Shines At ATS, But Experts Question Which Novel Biologic Physicians Will Choose

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.

Dupixent Hits Endpoints In Adolescents, Filing Expected In Q3

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.

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