INDIA – The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization for Sanofi India’s Dupixent (dupilumab) for the treatment of adult patients with atopic dermatitis.
Dupixent is also approved for marketing in the United States, the European Union, Japan, and more than 60 countries for multiple indications other than atopic dermatitis.
Atopic dermatitis, a form of eczema, is a chronic type 2 inflammatory disease with symptoms often appearing as a rash on the skin.
In India, Dupixent is now fully authorized for use as a biologic medicine in adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Dupixent is being developed by Sanofi Healthcare India Private Limited, formerly Aventis Pharma Ltd, a subsidiary of Sanofi, and Regeneron under a global collaboration agreement.
This decision comes as Sanofi Healthcare India Private Limited is looking to demerge its consumer healthcare business into a new wholly-owned subsidiary, Sanofi Consumer Healthcare India Ltd.
Moreover, the French pharmaceutical giant Sanofi plans to broaden its presence in India with an enhanced portfolio of products.
In a press release, the healthcare company said: “Globally, Dupixent 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.”
Patients treated with Dupixent achieved a more significant reduction in rashes covering the body, intense, persistent itching, skin dryness, cracking, redness, crusting, and oozing on the affected areas of the skin.
Sanofi India is expanding the treatment options for eligible people living with atopic dermatitis in the country. So far, more than 600,000 patients are being treated with Dupixent globally.
Dupixent will be available as an option for controlling moderate to severe atopic dermatitis for adults in India and it can be used along with or without topical therapy.
“Dupixent receiving marketing authorization in India is a significant milestone. We can offer our first-in-class and best-in-class therapy to treat people living with atopic dermatitis in India,” stated Sanofi India.
In India, the prevalence of atopic dermatitis among the adult population ranges between 2 % and 8 %.
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.
Sanofi India presents a unique treatment option for Indian patients at a time when the prevalence of atopic dermatitis in adults in India is on the rise.
CDSCO’s decision to authorize Dupixent marks a significant step forward in the company’s mission to improve the lives of people with moderate-to-severe atopic dermatitis around the world.
The authorization was based on clinical studies of Dupixent showing that it helps clear the skin, manage the persistent debilitating itch, and improve the overall quality of life along with proven long-term safety.
Commenting on this authorization, Anil Raina, General Manager, Sanofi Specialty Care (India), said: “Dupixent 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.”
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