FDA Approves New Option for Chronic Hives

Sanofi-Regeneron’s Dupixent gets FDA’s nod for skin condition

(Reuters) -The U.S. Food and Drug Administration approved the use of Sanofi and Regeneron’s blockbuster drug Dupixent for patients with a type of skin condition, the two companies said on Friday. The agency’s green light is a victory for the companies, as the FDA had declined to approve the drug for the skin condition in 2023 and had sought more efficacy data. Dupixent is now cleared with allergy medication for patients aged 12 years and older w…

FDA Approves New Option for Chronic Hives

(MedPage Today) -- The FDA approved dupilumab (Dupixent) for chronic spontaneous urticaria (CSU) in patients 12 years and older, the first new targeted drug for the inflammatory skin disease in over a decade, drugmakers Regeneron and Sanofi announced...

Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales potential compared to other emerging medicines for the condition.

Companies claim that they expect the population of ECU patients eligible for Dupixent to exceed 300,000 in the United States

FDA Approves Dupilumab, Marking First Targeted Therapy in a Decade for Chronic Spontaneous Urticaria

Multiple phase 3 clinical trials demonstrated dupilumab’s (Dupixent; Regeneron, Sanofi) effectiveness in reducing hives and itch in patients with chronic spontaneous urticaria compared with placebo.

FDA Approves Dupixent for Inflammatory Skin Disease

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