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J&J gets expanded approval for psoriasis drug from US FDA

The U.S. Food and Drug Administration approved an expanded indication for Johnson & Johnson unit Janssen Biotech Inc.'s Stelara to treat moderate to severe plaque psoriasis in patients aged 12 years or older who are candidates for phototherapy or systemic therapy.

Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells.

The approval of Stelara is based on data from a phase 3 study, where at least two-thirds of patients aged 12 years or older responded to the drug after just two doses.

Safety findings for adolescent patients treated with the drug were consistent with those seen in studies in adults with the disease.