Aurobindo Pharma Subsidiary Gains USFDA Nod for ADQUEY Ointment

Aurobindo Pharma Ltd, through its wholly owned step-down subsidiary Acrotech Biopharma Inc., has announced the receipt of U.S. FDA approval for its New Drug Application (NDA) for ADQUEY (difamilast 1%) ointment. This approval is for the topical treatment of mild-to-moderate atopic dermatitis in adults and pediatric patients aged 2 years and older. The product is a non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor, offering a new treatment option for patients with this condition.

The financial terms related to the approval of ADQUEY have not been disclosed in the filing. However, the approval is expected to enhance Acrotech Biopharma’s product offerings in the dermatology segment. The company, a subsidiary of Aurobindo Pharma, focuses on developing and commercializing innovative proprietary medications. The approval of ADQUEY is a strategic addition to its portfolio, potentially increasing its market share in the U.S. pharmaceutical market.

The operational scope of ADQUEY involves its formulation as a topical ointment designed for twice-daily application. It is indicated for patients with mild-to-moderate atopic dermatitis, a condition characterized by itchy, dry, and inflamed skin. The product’s efficacy was demonstrated in pivotal Phase III controlled trials, where a significantly greater proportion of patients treated with ADQUEY achieved Investigator’s Global Assessment (IGA) success compared to placebo after four weeks of treatment. The safety profile was consistent across all trials, with nasopharyngitis being the most common adverse reaction reported.

The timeline for the development and approval of ADQUEY included multiple clinical trials, culminating in the FDA’s approval on February 13, 2026. The product has been licensed to Acrotech Biopharma by Otsuka Pharmaceutical Co., Ltd. since 2021. The company plans to make the treatment available to patients in the U.S. market promptly following this approval.

Acrotech Biopharma Inc., a subsidiary of Aurobindo Pharma, is responsible for the commercialization of ADQUEY in the United States. The company collaborates with Otsuka Pharmaceutical Co., Ltd., which discovered and developed difamilast. Otsuka is involved in the healthcare sector, focusing on treatments and diagnostics for physical and mental health. Acrotech’s role involves bringing scientifically advanced products to market, addressing unmet medical needs.

The market context for ADQUEY involves its positioning as a non-steroidal treatment option for atopic dermatitis, a common chronic condition affecting millions of individuals. The approval of ADQUEY expands the treatment options available to dermatologists and patients, potentially impacting the competitive landscape in the dermatology sector. The product’s approval aligns with Aurobindo Pharma’s strategic focus on expanding its specialty pharmaceutical offerings.

Otsuka Pharmaceutical Co., Ltd. is a healthcare company that provides treatments and diagnostics for both physical and mental health. The company focuses on creating new products for better health worldwide, supporting daily health maintenance and improvement.

Aurobindo Pharma Limited is a global pharmaceutical company headquartered in Hyderabad, India. It develops, manufactures, and commercializes a wide range of generic and branded specialty pharmaceuticals. The company operates in over 150 countries and has a robust product portfolio across several therapeutic areas, supported by a strong R&D setup.