Aurobindo Pharma arm Acrotech gets FDA nod for eczema ointment ADQUEY

Hyderabad-based drug major Aurobindo Pharma Ltd on Friday (February 13), said its step-down subsidiary, Acrotech Biopharma Inc, in collaboration with Otsuka Pharmaceutical Co Ltd, announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ADQUEY (difamilast 1%) ointment.

The ointment is approved for the topical treatment of mild-to-moderate atopic dermatitis in adults and paediatric patients aged two years and older. Acrotech Biopharma develops and commercialises proprietary bio-pharmaceutical medications and focuses on innovative therapies in collaboration with global partners.

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.

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Ashish Anvekar, President of Acrotech Biopharma Inc, said, "The approval of ADQUEY represents a significant milestone in our commitment to advancing dermatology care. 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 US as soon as possible."

What is atopic dermatitis?

According to the American Academy of Dermatology, 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.

What is ADQUEY?

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 two years of age and older.

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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.

Shares of Aurobindo Pharma Ltd ended at ₹1,155.45, down by ₹2.10, or 0.18%, on the BSE today, February 13.