Dupixent (dupilumab), the co-developed eczema injection from pharma giants Sanofi and Regeneron Pharmaceuticals, has got the US FDA approval for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients.
Dupixent eczema injection with that has become the first ever biologic medicine approved for atopic dermatitis treatment in patients whose disease is not managed adequately through topical prescription treatments, or in whom the therapies are not advisable.
Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research on the Dupixent eczema injection approval said: “FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease.
“Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies.”
The new eczema injection Dupixent has been made available with medical providers and patients in the US following its regulatory approval. Its marketing in the country will be handled by Sanofi’s specialty care global business unit – Sanofi Genzyme and Regeneron.
Commenting on the FDA approval of Dupixent eczema injection, Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi said: “We strive to transform scientific innovation into therapeutic solutions that make a meaningful difference to people’s lives.
“The approval of Dupixent offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally.”
A chronic inflammatory disease with symptoms mostly appearing as a skin rash, atopic dermatitis is the most common form of eczema. In the moderate to severe forms, the skin disease can be recognized by rashes that mostly cover almost all of the body. Besides, patients suffer from intense, constant itching and dryness in the skin, redness, cracking, oozing and crusting.
Itch as per health experts is considered to be one of the most troublesome symptoms which can make patients very weak.
The newly FDA approved Dupixent eczema injection comes as a new treatment option for an estimated 300,000 patients in the US suffering from moderate-to-severe atopic dermatitis.
Its approval comes less than a month after Sanofi and Regeneron reported a successful phase 3 outcome in which Dupixent eczema injection along with topical corticosteroids (TCS) was shown to have significantly brought down the intensity of the overall disease in comparison to TCS alone. Here are the details of the findings of the atopic dermatitis clinical trial of the eczema drug Dupixen.