NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) Monday said it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for icotrokinra for the treatment of individuals aged 12 years and older with plaque psoriasis.
The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2. Treatment with icotrokinra met all primary goals across the studies.
The company has also initiated the Phase 3 ICONIC-ASCEND study, to show the superiority of an oral pill, icotrokinra, compared to an injectable ustekinumab.
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