Acrotech Biopharma Inc, working alongside Otsuka Pharmaceutical Co, Ltd, announced that the US Food and Drug Administration has approved the New Drug Application for ADQUEY™ (difamilast 1%) ointment. The therapy is indicated for topical treatment of mild-to-moderate atopic dermatitis in adults and children aged two years and older.
ADQUEY is a non-steroidal topical phosphodiesterase 4 (PDE4) inhibitor, offering a steroid-free alternative for individuals managing atopic dermatitis, commonly known as eczema. The condition is characterized by chronic inflammation, dryness, and persistent itching, affecting millions across the United States.
Ashish Anvekar, President of Acrotech Biopharma Inc, described the approval as an important advancement for dermatology patients seeking long-term treatment options that address both inflammation and itch without relying on steroids. The company plans to make the product available in the U.S. market in the near term.
Regulatory clearance was supported by several studies, including pivotal Phase III controlled trials. Results showed that a significantly higher percentage of patients treated with ADQUEY achieved Investigator’s Global Assessment (IGA) success at four weeks compared with those receiving vehicle (placebo).
The safety profile remained consistent across trials. The most frequently reported adverse reaction (occurring in at least 1% of patients and more often than placebo) was nasopharyngitis. ADQUEY is formulated as a twice-daily topical ointment for patients aged two and older with mild-to-moderate atopic dermatitis. Difamilast inhibits all PDE4 subtypes and was originally discovered and developed by Otsuka Pharmaceutical Co, Ltd US rights have been licensed to Acrotech since 2021.
Acrotech Biopharma Inc was established as a global platform dedicated to bringing innovative, proprietary medicines to market. The company is committed to introducing scientifically advanced products that address unmet medical needs while creating value for patients and the broader healthcare community. Acrotech strives to be a patient-focused, research-driven organization, working to make essential treatments accessible to those who need them most.
