Binetrakin

GOLD 2025 updates COPD management, removing ICS/LABA from initial therapy and adding ensifentrine for symptom relief and dupilumab for high eosinophil count patients, emphasizing tailored treatment based on symptoms or exacerbations.

The atopic dermatitis market is projected to grow from $7.51 billion in 2023 to $15.27 billion by 2028, driven by advancements in biologic therapies, personalized medicine, and product innovations. Key players include Sanofi SA, Regeneron Pharmaceuticals Inc., and Novartis International AG.

FDA accepts Sanofi and Regeneron's resubmitted sBLA for Dupixent in chronic spontaneous urticaria, targeting 18 April 2025 decision. Dupixent, inhibiting IL-4 and IL-13 pathways, showed significant itch and urticaria reduction in LIBERTY-CUPID Phase 3 studies. Safety consistent with established profile; common adverse events include injection site reactions and COVID-19 infections. Dupixent approved for CSU in Japan and UAE, under review in EU, and has broader approvals for various inflammatory conditions.

FDA accepts dupilumab's sBLA for chronic spontaneous urticaria treatment, targeting April 18, 2025 for approval. Dupilumab, an IL-4 and IL-13 inhibitor, aims to treat CSU not controlled by H1 antihistamines. Studies A, B, and C in the LIBERTY-CUPID program support the application, showing dupilumab's efficacy in reducing itch and urticaria activity.

FDA accepts Regeneron and Sanofi's resubmission of Dupixent for chronic spontaneous urticaria (CSU) review, with a decision expected by April 18, 2025. Dupixent, if approved, would be the first targeted therapy for CSU in a decade, supported by pivotal data showing significant itch and hive activity reduction.

FDA reviews Sanofi and Regeneron’s Dupixent for chronic spontaneous urticaria, targeting decision by April 2025. Dupixent, a monoclonal antibody, inhibits IL-4 and IL-13 pathways, showing significant itch and urticaria reduction in Study C. Already approved in Japan and UAE, Dupixent seeks EU approval and has potential revenue of $23.6bn by 2030.

FDA accepts Regeneron and Sanofi's resubmission of sBLA for Dupixent to treat chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 and older, with a decision expected by April 18, 2025. The resubmission includes pivotal data confirming Dupixent's significant reduction in itch and hive activity, supported by the LIBERTY-CUPID Phase 3 clinical program. If approved, Dupixent would be the first targeted therapy for CSU in a decade.

Regeneron and Sanofi's Dupixent gains FDA approval for COPD, becoming the first targeted therapy for the condition, with a Phase 3 trial showing reduced exacerbations and improved lung function.

FDA expands DUPIXENT use for COPD, offering new treatment options for patients. COPD affects 44 million in 7MM, with cases expected to rise. DUPIXENT targets IL-4 and IL-13 pathways, reducing exacerbations and improving lung function.

Chronic rhinosinusitis with nasal polyps (CRSwNP) affects 1.1% of U.S. adults, impairing quality of life. FDA-approved biologics (dupilumab, mepolizumab, omalizumab) target type 2 inflammation, showing efficacy in reducing polyp size and improving symptoms. Optimal use, treatment duration, and patient selection for biologics remain unclear, necessitating further research and shared decision-making.