Aurobindo Pharma announced that its stepdown subsidiary, Acrotech Biopharma Inc., has received U.S. FDA approval for ADQUEY™ (difamilast 1%) Ointment. This novel, non-steroidal topical treatment is indicated for the mild-to-moderate atopic dermatitis (eczema) in patients aged 2 and older. The approval is based on positive results from pivotal Phase III trials demonstrating efficacy against inflammation and pruritus associated with the chronic skin condition.
FDA Approval for ADQUEY™ (Difamilast 1%) Granted
Aurobindo Pharma Limited has confirmed that its subsidiary, Acrotech Biopharma Inc., has successfully obtained New Drug Application (NDA) approval from the U.S. Food and Drug Administration (FDA). The approved product is ADQUEY™ (difamilast 1%) Ointment.
This approval grants marketing authorization for the topical treatment of mild-to-moderate atopic dermatitis (AD) in both adult and pediatric patients aged 2 years and older. ADQUEY is notable as a novel, non-steroidal topical phosphodiesterase 4 (PDE4) inhibitor, offering an important new treatment avenue for millions of Americans living with eczema.
Clinical Efficacy and Safety Profile
The FDA approval was supported by extensive data, including pivotal Phase III controlled trials. These studies demonstrated that a significantly greater proportion of patients treated with ADQUEY achieved Investigator’s Global Assessment (IGA) success compared to the vehicle (placebo) after four weeks of treatment.
The overall safety profile remained consistent across all trials. The most common adverse reaction reported (≥1% and greater than vehicle) was nasopharyngitis (6%). Less common reactions included application site folliculitis, contact dermatitis, and molluscum contagiosum.
Product and Development Details
ADQUEY is formulated for twice-daily application and demonstrates inhibitory activities on all phosphodiesterase (PDE) 4 subtypes. Difamilast, the active ingredient, was originally discovered and developed by Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical is a collaborator in this venture, while Acrotech has held the U.S. license since 2021.
Acrotech Biopharma, a step-down subsidiary of Aurobindo, is positioned globally to commercialize innovative proprietary medications, aiming to deliver patient-focused, research-based treatments to address unmet medical needs in dermatology.
Forward-Looking Statement Disclaimer
This press release contains statements that may constitute “forward looking statements” regarding expected product characteristics, sales potential, and launch dates. Actual results may differ materially due to various risks and uncertainties. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect future events or circumstances.
Source: BSE
