In an incredible move for adolescent patients 12 to 17 years of age, the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for patients with moderate-to-severe atopic dermatitis. Specifically, this is for patients whose disease is not adequately controlled with topical prescription therapies.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) is ultimately the beneficiary of this approval after the FDA evaluated Dupixent’s application under Priority Review.
Dupixent was also previously granted Breakthrough Therapy designation by the FDA for inadequately controlled moderate-to-severe atopic dermatitis in adolescents.
In the Phase 3 trial evaluating Dupixent in adolescent patients with uncontrolled moderate-to-severe atopic dermatitis, the safety and efficacy were generally consistent with that previously seen in adult studies.
A few of the highlights from the study included:
- The average improvement in the Eczema Area and Severity Index (EASI) from baseline was approximately 66% compared to 24% for placebo.
- More than 10 times as many patients had clear or almost clear skin with Dupixent compared to placebo: 24% of patients who received Dupixent achieved clear or almost clear skin compared to 2% with placebo.
- Over five times as many patients saw overall disease improvement of at least 75% with Dupixent compared to placebo: 42% of patients who received Dupixent achieved 75% or greater skin improvement compared to 8% with placebo.
- Over seven times as many patients experienced significantly reduced itch with Dupixent compared to placebo: 37% of patients who received Dupixent achieved a clinically meaningful improvement in itch of at least four points on the Peak Pruritus Numerical Rating Scale (NRS) compared to 5% with placebo.
Shares of Regeneron closed Monday up about 2% at $410.45, with a 52-week range of $281.89 to $442.00. The stock has a consensus analyst price target of $430.24.
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