Dupixent plus TCS reduced overall disease severity in children by 70% and itch by 49%

A pivotal Phase III trial evaluating Dupixent (dupilumab) for the treatment of children aged six months to five years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints.

The data show adding Dupixent to standard of care topical corticosteroids (TCS) significantly reduced overall disease severity and improved skin clearance, itch, and health-related quality of life measures at 16 weeks compared to TCS alone. Dupixent is the first biologic medicine to show positive results in this young population and remains the only approved biologic medicine in patients 6 years and older with uncontrolled moderate-to-severe atopic dermatitis.

Dupixent, which is marketed by France’s Sanofi (Euronext: SAN) and Regeneron (Nasdaq: REGN), yielding full-year revenues of 3.5 billion euros in 2020 ($4.1 billion), and 1.24 billion euros, up 57%, in the second quarter of this year, and Sanofi has an ambitious target of up to $12 billion in peak annual sales.