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 | REGN Price Prediction) 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.
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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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