DCGI gives approval for Dupilumab to treat Atopic Dermatitis

Dupixent can be used along with or without topical therapy.

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DCGI CDSCO Regulator Drugs Controller General India
DCGI

Last Updated on December 31, 2023 by The Health Master

Drugs Controller General of India (DCGI) gives approval for marketing authorisation to Sanofi Healthcare India for Dupixent (dupilumab), the first biologic medicine for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Dupixent can be used along with or without topical therapy.

Globally, Dupixent (dupilumab) has transformed the treatment landscape for patients around the world by targeting the type 2 inflammation that underlies the disease, rather than broadly suppressing the immune system.

Anil Raina, GM, Sanofi Specialty Care (India), “Approved in the US, the European Union, Japan and more than 60 countries for one or more indications other than atopic dermatitis, Dupixent (dupilumab) is the first and only biologic medicine in India that has shown significantly improved disease signs, symptoms, and quality of life measures, for this particularly difficult-to-treat skin condition.”

Atopic dermatitis, a form of eczema, is a chronic type 2 inflammatory disease with symptoms often appearing as a rash on the skin.

Moderate-to-severe atopic dermatitis is characterised by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.

Dr Shalini Menon, Country Medical Lead, Sanofi (India), “People living with moderate-to-severe atopic dermatitis can experience unbearable symptoms and have significantly impaired quality of life, including disrupted sleep, and increased anxiety and depression symptoms.”

“The chronicity and often visible lesions lead to considerable social stigma. Through studies Dupixent (dupilumab) has shown that it helps clear the skin, manage the persistent debilitating itch, and improve overall quality of life along with proven long-term safety.”

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

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