Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...

The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

Medically reviewed by Jurairat J. Molina, MD Acute urticaria (hives) is a common skin condition that affects up to 20% of people at some point in their lives. It can transition into chronic urticaria ...

1 While second-generation H1-antihistamines are standard therapy for both acute and chronic urticaria, some patients need additional treatment to find relief. A new study investigates whether ...

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

Novartis’ immunoglobulin E inhibitor Xolair has been a mainstay of treatment for chronic spontaneous urticaria (CSU) for many years, but the company says it has gone one better with new ...

Novartis is just months away from filing for approval of oral BTK inhibitor remibrutinib as a treatment for chronic spontaneous urticaria – also known as chronic hives – after reporting long ...

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...