The pharmaceutical company Sanofi recently obtained approval for a new indication for the biotechnologically produced antibody Dupilumab. The drug can now be used for children from the age of 6 years and adolescents with severe atopic dermatitis, as the company announced.
The European Commission approved the expanded use of Dupilumab based on the results of a phase 3 clinical trial. The study showed that treatment with Dupilumab significantly improved the skin lesions and itching in young patients with severe atopic dermatitis. Furthermore, Dupilumab did not show any new safety concerns during the study.
Dupilumab is already approved for adults with moderate to severe atopic dermatitis and for adolescents aged 12 years and older with moderate to severe atopic dermatitis who do not respond to, or are not suitable candidates for, topical treatments.
Atopic dermatitis, also known as eczema, is a chronic inflammatory skin disease that can severely affect the quality of life of those affected. The condition is characterized by itchy, inflamed skin lesions that can cause significant discomfort and distress.
With the new indication for Dupilumab in younger patients, it is hoped that more children and adolescents suffering from severe atopic dermatitis will now have access to an effective treatment option that can help alleviate their symptoms and improve their quality of life.
Original source: This information was Initially covered by Pharmazeutische-zeitung.de and has been translated for our readers.