France-based pharmaceutical major Sanofi (EPA: SAN, NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has approved its Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU). The approval applies to patients who continue to experience symptoms despite treatment with histamine-1 (H1) antihistamines.
First New Treatment in Over a Decade
Dupixent represents the first new targeted treatment for CSU in over ten years. The drug has demonstrated significant efficacy in reducing the intense itching and unpredictable hives associated with CSU in pivotal trials. This approval expands Dupixent’s indications to seven chronic, debilitating atopic conditions driven by underlying type 2 inflammation.
Global Approval Momentum
Dupixent has previously received approval for CSU in Japan, the United Arab Emirates, and Brazil. The FDA’s approval further solidifies the drug’s position as a global leader in treating conditions linked to type 2 inflammation.-Fineline Info & Tech