Acrotech Biopharma, in collaboration with Otsuka Pharmaceutical, has secured approval from the US FDA for ADQUEY (difamilast 1%) ointment, marking a significant new treatment option for patients living with mild-to-moderate atopic dermatitis.
The newly approved therapy is indicated for adults and children aged two and older, offering a novel, non-steroidal topical phosphodiesterase 4 (PDE4) inhibitor designed to treat both inflammation and itching associated with eczema.
ADQUEY’s approval opens the door to a new alternative for millions of Americans struggling with atopic dermatitis — a chronic condition that causes itchy, dry, and inflamed skin and often begins in childhood.
"The approval of ADQUEY represents a significant milestone in our commitment to advancing dermatology care," said Ashish Anvekar, President of Acrotech Biopharma Inc. "Patients and clinicians have long sought effective, long-term, non-steroidal treatments that can manage both the inflammation and pruritus associated with eczema. We intend to bring this valuable treatment option to the patients in the US as soon as possible."
The FDA’s decision was supported by multiple studies, including pivotal Phase III controlled trials. Results showed a significantly greater proportion of patients treated with ADQUEY achieved Investigator’s Global Assessment (IGA) success compared to vehicle (placebo) after four weeks of treatment.
Safety findings were consistent across three trials. The most common adverse reaction (≥1% and greater than vehicle) was nasopharyngitis. Less common adverse reactions (under 1%) included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.
ADQUEY is formulated for twice-daily topical application and inhibits all phosphodiesterase 4 (PDE4) subtypes. The drug was originally discovered and developed by Otsuka Pharmaceutical and has been licensed to Acrotech in the United States since 2021.
With FDA approval now secured, Acrotech is preparing to launch ADQUEY in the US, positioning it as a long-awaited non-steroidal alternative in the eczema treatment landscape.
