FDA Approves Adquey (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis

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FDA Approves Adquey (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis

East Windsor, NJ - February 13, 2026 - Acrotech Biopharma Inc., a bio-pharmaceutical company focused on developing and commercializing innovative propriety 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."

Clinical Trial Results 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.

About Atopic DermatitisAtopic 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. (Source: American Academy of Dermatology)

About Adquey (difamilast 1%)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.

Indication Adquey is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis.

Important Safety InformationThe most common adverse reactions reported (≥1%) for Adquey ointment was nasopharyngitis (6%). Please see full Prescribing Information for Adquey.

About Acrotech BiopharmaAcrotech Biopharma Inc (“Acrotech”) a step-down subsidiary of Aurobindo Pharma Ltd, India was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patients as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research-based organization that strives to launch treatments which are accessible to patients that need them. To learn more about Acrotech Biopharma, visit acrotechbiopharma.com

About OtsukaOtsuka Pharmaceutical Co., Ltd. (“Otsuka”) is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit www.otsuka.co.jp

About Aurobindo Pharma LimitedAurobindo Pharma Limited (www.aurobindo.com), (NSE: AUROPHARMA, BSE: 524804, Reuters: ARBN.NS, Bloomberg: ARBP IN) is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

The company has 31 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s robust product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and AntiAllergic, supported by a strong R&D set-up.

Disclaimer: This press release contains statements that may constitute “forward looking statements” including and without limitation, statements relating to product characteristics and uses, sales potential and target dates for product launch, implementation of strategic initiatives, and other statements relating to our future business developments and economic performance. While these forward-looking statements represent our judgment and future expectations concerning the development of our business, a number of risks, uncertainties and other factors could cause actual developments and results to differ materially from our expectations. The company undertakes no obligation to publicly revise any forward-looking statements to reflect future events or circumstances and will not be held liable for any use of this information.

Source: Aurobindo Pharma Limited

Source: HealthDay

Adquey (difamilast) FDA Approval History

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    Posted : 2026-02-20 09:26

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