Aurobindo's Acrotech Receives FDA Approval for ADQUEY, First Non-Steroidal PDE4 Inhibitor for Atopic Dermatitis
核心洞察
Acrotech Biopharma (搜索), a subsidiary of Aurobindo Pharma, received FDA approval for ADQUEY (搜索) (difamilast 1%) ointment, a novel non-steroidal topical PDE4 (搜索) inhibitor for mild-to-moderate atopic dermatitis (搜索) in patients aged 2 and older.
Pivotal Phase III trials demonstrated significantly greater IGA success rates compared to placebo after four weeks of treatment, with nasopharyngitis being the most common adverse reaction at 6%.
The approval addresses an unmet medical need for effective, long-term non-steroidal treatments that manage both inflammation and pruritus associated with eczema (搜索) in millions of Americans.
Aurobindo Pharma Limited announced on February 13, 2026, that its wholly owned step-down subsidiary Acrotech Biopharma (搜索) Inc. has received US FDA approval for ADQUEY (搜索)™ (difamilast 1%) ointment for the topical treatment of mild-to-moderate atopic dermatitis (搜索) in adults and pediatric patients aged 2 and older. This approval marks a significant advancement in dermatology care, providing the first non-steroidal, topical phosphodiesterase 4 (搜索) (PDE4 (搜索)) inhibitor for treating this chronic inflammatory skin condition.
Novel Mechanism of Action
ADQUEY (搜索) represents a breakthrough in atopic dermatitis (搜索) treatment as a novel, non-steroidal, topical PDE4 (搜索) inhibitor formulated as an ointment for twice-daily application. The drug demonstrates inhibitory activities on all phosphodiesterase 4 (搜索) subtypes, offering a new therapeutic approach for managing the inflammation and pruritus associated with eczema (搜索).
Difamilast was discovered and developed by Otsuka Pharmaceutical (搜索) Co., Ltd., which licensed the compound to Acrotech in the United States since 2021. This collaboration enabled Acrotech to successfully navigate the regulatory approval process and bring this innovative treatment to American patients.
Clinical Trial Results
FDA approval was supported by multiple studies, including pivotal Phase III controlled trials that demonstrated the efficacy and safety of ADQUEY (搜索). The clinical data showed 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 remained consistent across all three trials. The most common adverse reaction was nasopharyngitis, occurring in 6% of patients. Less common adverse reactions (< 1%) included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.
Addressing Unmet Medical Need
Atopic dermatitis (搜索), also called eczema (搜索), is a common and chronic condition that causes itchy, dry, and inflamed skin, affecting millions of Americans. The condition usually begins in childhood but can start at any age, creating a substantial burden for patients and healthcare systems.
"The approval of ADQUEY (搜索) represents a significant milestone in our commitment to advancing dermatology care," said Ashish Anvekar, President of Acrotech Biopharma (搜索) Inc. "Patients and clinicians have long sought effective, long-term, non-steroidal treatments that can manage both the inflammation and pruritus associated with eczema (搜索). We intend to bring this valuable treatment option to the patients in the U.S. as soon as possible."
Company Background
Acrotech Biopharma (搜索) Inc. serves as a step-down subsidiary of Aurobindo Pharma Ltd and operates as a global platform to commercialize innovative proprietary medications. The company focuses on launching scientifically advanced products to address unmet needs and deliver value to patients and healthcare stakeholders.
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India, with operations spanning over 150 countries. The company operates 31 manufacturing and packaging facilities approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, and Health Canada.