The European Commission today granted marketing authorization to dupilumab (Dupixent, Samofi and Regeneron) for adults with moderate to severe atopic dermatitis, according to a company news release.
Dupilumab can be used with or without topical corticosteroids. Its safety and effectiveness in children are not known.
A panel of the European Medicines Agency (EMA) recommended dupilumab for this indication on July 21 this year, as previously reported by Medscape Medical News.
“Dupixent targets an underlying cause of atopic dermatitis, helps clear the skin, manage the persistent debilitating itch, and improve overall quality of life,” Elias Zerhouni, MD, president of Global R&D at Sanofi, said in the news release.
Dupilumab is a human monoclonal antibody that inhibits overactive signaling of IL-4 and IL-13, which are thought to be the primary drivers of the ongoing underlying inflammation that occurs in atopic dermatitis, among other disorders.
Dupilumab will be available in a premixed syringe for biweekly injection.
At last year’s European Academy of Dermatology and Venereology Congress in Vienna, Eric L. Simpson, MD, of the Oregon Health and Science University in Portland, told Medscape Medical News, “This is a much-needed therapy for patients who have few options.
“Not only are there significant effects on itch and other skin symptoms, but the patients’ overall quality of life is restored. Even symptoms of anxiety and depression improved in a relatively short amount of time,” he said.
Dupilumab also was approved in the United States in March this year for use in adults with moderate to severe atopic dermatitis (a form of eczema) that is poorly controlled with prescription topical treatments or those who cannot use topical treatments.
The EMA’s decision follows results from studies that included 3000 patients with moderate to severe atopic dermatitis who received dupilumab alone (LIBERTY AD studies, including SOLO 1, SOLO 2, CHRONOS) or in combination with topical corticosteroids (SOLO-CONTINUE and CAFÉ). Patients’ conditions had previously been uncontrolled with the original therapies. All patients met the primary and secondary endpoints on their study medications.
The most frequent adverse events were seen in patients taking the higher dose of medication compared to those taking placebo in the dupilumab group (>1%). These included injection site reactions; eye and eyelid inflammation, including redness, swelling, and itching; and cold sores in the mouth or on the lips.
Dupilumab is currently being evaluated for the treatment of atopic dermatitis in a program that includes studies in children aged 6 months to 11 years who have severe atopic dermatitis and studies in patients aged 12 to 17 years who have moderate to severe atopic dermatitis.
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