Mumbai, July 11, 2023. Sanofi Healthcare India Pvt. Ltd. today announced that it has received marketing authorization 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® 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, General Manager, Sanofi Specialty Care (India)
“Dupixent® receiving marketing authorization in India is a significant milestone, as we now have the opportunity to offer our first-in-class and best-in-class therapy to treat people living with atopic dermatitis, in India. Approved in the U.S., the European Union, Japan and more than 60 countries for one or more indications other than atopic dermatitis, 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.”
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 characterized 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)
“The prevalence of atopic dermatitis in adults in India ranges from 2 % to 8 %* and there has been a trend* of increasing prevalence observed in India. Many often struggle to control their disease with the treatment options currently available. Itching is one of the most burdensome symptoms for patients and can be debilitating. 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® 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.”
With more than 600,000 patients being treated with Dupixent® globally, Dupixent® will soon be available as an option for controlling moderate to severe atopic dermatitis for adults in India. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Sanofi – in India for India
Since 1956, Sanofi has earned the trust as well as a place in 1-in-3 Indian households (if not more). Pain management (Combiflam®), respiratory allergies caused by pollution (Allegra®), vitamin D deficiency (Depura®), diabetes (Lantus® - insulin glargine), flu prevention (FluQuadri® vaccine) and rare diseases (4 first & best-in-class therapies) are significant health issues, and our portfolio helps prevent, treat or optimally manage them. Six of our brands feature amongst India’s Top 200 pharmaceutical brands*. Sanofi also provides devices (insulin pens), counselling (Saath7 for patients on Lantus®), diagnostic services for rare diseases (Disha), health education and awareness (mass & social media and in-clinic), and capacity building (HCPs & educators) in order to provide people in India holistic care for better disease outcomes. Our India Charitable Access Program is the country’s longest running humanitarian program providing free treatment to people afflicted with Lysosomal Storage Disorders. We conduct clinical trials here so that India can have quicker access to the latest from our global pipeline. Our world-class manufacturing site in Goa produces for people in India and 60+ other countries.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.
*Source: Tsai TF, Rajagopalan M, Chu CY, Encarnacion L, Gerber RA, Santos‐Estrella P, Llamado LJ, Tallman AM. Burden of atopic dermatitis in Asia. The Journal of dermatology. 2019 Oct;46(10):825-34.
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