Aurobindo Arm Acrotech Secures USFDA Nod for Atopic Dermatitis Drug ADQUEY

New Delhi: Aurobindo Pharma Limited announced that its wholly owned step-down subsidiary, Acrotech Biopharma, has received approval from the U.S. Food and Drug Administration (FDA) for ADQUEY (difamilast 1%) ointment, indicated for the topical treatment of mild-to-moderate atopic dermatitis.

Acrotech Biopharma, a biopharmaceutical company focused on developing and commercializing innovative proprietary medications, in collaboration with Otsuka Pharmaceutical Co., Ltd., today announces that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ADQUEY (difamilast 1%) ointment for the topical treatment of mild-to-moderate atopic dermatitis (AD) in adults and pediatric patients aged 2 and older.

ADQUEY is a novel, non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor. This approval provides a new non-steroidal, topical treatment option for the millions of Americans living with atopic dermatitis.

"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 U.S. as soon as possible."

FDA approval was supported by multiple studies, including pivotal Phase III controlled trials, which demonstrated that 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. The safety profile of ADQUEY AD was consistent across all three trials. The most common adverse reactions (≥1% and greater than vehicle) was nasopharyngitis. Less common (<1%) adverse reactions in subjects treated with ADQUEY included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.

Atopic dermatitis, also called eczema, is a common and chronic condition that causes itchy, dry, and inflamed skin. It usually begins in childhood but can start at any age.

ADQUEY is a novel non-steroidal phosphodiesterase 4 (PDE-4) inhibitor formulated as a topical ointment designed for twice-daily application for the treatment of mild to moderate atopic dermatitis in patients 2 years of age and older. ADQUEY demonstrates inhibitory activities on all phosphodiesterase (PDE) 4 subtypes. Difamilast was discovered and developed by Otsuka Pharmaceutical and has been licensed to Acrotech in the United States since 2021.

ADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. The most common adverse reaction reported (≥1%) for ADQUEY ointment was nasopharyngitis (6%).