AbbVie submits NDA to FDA, MAA to EMA for upadacitinib

AbbVie announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration and a marketing authorization application to the European Medicines Agency for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis. The NDA and MAA are supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five Phase 3 studies. In all studies, upadacitinib met all primary and ranked secondary endpoints. The most frequent serious adverse events were infections. Top-line results from these clinical studies were previously announced. Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
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