The FDA has approved Dupixent as the first new targeted therapy in over ten years for chronic spontaneous urticaria in patients aged 12 and older who remain symptomatic despite antihistamine treatment ...

The CSU indication is the seventh disease driven in part by underlying type 2 inflammation in which Dupixent has received approval.

Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) for chronic ...

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) to treat adults and ...

Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new ...

Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...

But other pathways play a role in CSU. Dupixent, a drug administered by injection every two weeks, is a monoclonal antibody designed to block the signaling pathways IL-13 and IL-4. Dupixent’s ...

Chronic spontaneous urticaria is chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden ...

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria Approval based on phase 3 ...

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) for the treatment of chronic spontaneous ...

In pooled data from all three trials, the most common adverse event (≥2%) more frequently observed in patients on Dupixent compared to placebo was injection site reactions. “CSU patients with ...